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Management provides pipeline update for assets including its COVID-19 vaccine and peptide therapeutic
New York, NY – June 03, 2020 — Hoth Therapeutics, Inc. (NASDAQ: HOTH), a biopharmaceutical company, today is providing an update on its pipeline of therapeutics including six compounds in various stages of clinical development, targeting atopic dermatitis, lupus as well as a COVID-19 vaccine and peptide therapeutic.
“Hoth has assembled a unique and portfolio of therapeutics, that is each addressing significant unmet market needs globally,” stated Mr. Robb Knie, CEO of Hoth Therapeutics. “We have partnered with some of the most renowned doctor, clinics, and scientific institutions as we strive to bring these innovative therapeutic solutions through the clinic. We have several significant milestones upcoming throughout the rest of 2020 into next year including our human study for BioLexa, targeting the treatment of eczema in adolescents. Management remains committed to developing, and bringing these novel treatments to market and improving the lives of those that require them.”
BioLexa Platform (Dermatological)
The BioLexa Platform is a proprietary antimicrobial therapy designed for the treatment of atopic dermatitis or eczema through a non-corticosteroid approach. In January 2020, Hoth concluded its “In-life 28-day animal study”. The BioLexa Platform has recorded positive results from its pilot project in 2019 and most recently obtained strong data from initial animal testing. Additionally the Company is preparing to begin its first trial in humans later this year.
VNLG-152 (Dermatological)
Earlier this year, Hoth acquired the full licensing rights of VNLG-152 novel retinamides (Retinoic acid metabolism blocking agents, or RAMBAs) for the treatment of dermatological diseases. The Company previously announced that pre-clinical work is underway at Weill Cornell Medicine to examine the efficacy of RAMBAs in blocking acne pathogenic gene expression and carcinogenesis in mice. Currently, Hoth is exploring whether VNLG-152 is capable of blocking this inflammatory response. Immediately after identifying an effective dose of VNLG-152, the researchers will conduct studies on mouse skin to determine if this drug is effective in blocking acne-like inflammation. As the Weill Cornell lab reopens later this month Hoth has intentions to finalize results of its preclinical work.
WEG-232 (Dermatological)
Last year Hoth entered into a research agreement with the George Washington University (GW) to explore the potential use of WEG-232 for topical and/or systemic therapy to counter the dermatological related side-effects of Erlotinib therapy in cancer patients. Erlotinib is a drug that is used to combat various cancers and has been known to cause varying degrees of skin rashes, lesions, hair loss and nail changes to patient. A recent research study suggested the topical application of WEG-232 could be very effective in suppressing erlotinib induced-facial rash/hair loss with approximate 71% reduction. It concluded that WEG-232 may be used as an effective intervention to prevent EGFR-TKI-induced cutaneous toxicity. Hoth looks forward to filing a pre-IND with the FDA this year to receive guidance and begin its human trial.
VaxCelerate (COVID-19)
VaxCelerate is self-assembling vaccine (SAV) platform designed to protect patients at risk of Coronavirus (COVID-19) infection. VaxCelerate is believed to offer unique advantages over other compounds in combination therapy. In infectious applications, it allows rapid development against viruses and other pathogens. The vaccine focuses on both DNA and internal / external mutated proteins providing the immune system with more potential targets to attack. VaxCelerate is currently in animal trials and will share those results as the testing completes.
Novel Peptide Therapeutic (COVID-19)
The Company recently licensed technology and intellectual property exclusively from Virginia Commonwealth University (“VCU”) for a novel peptide therapeutic to prevent spike protein binding, a potential leading cause of COVID-19. This treatment could be a breakthrough in slowing the transmission of the virus. Current research is being led by inventor, Michael H. Peters, Ph.D., Professor, Department of Chemical and Life Science Engineering at VCU, College of Engineering. The work is being aided, in part, by powerful supercomputers as part of the COVID-19 High Performance Computing Consortium through a virtual system that scientists can use to interactively share computing resources known as the Extreme Science and Engineering Discovery Environment. Hoth hopes to have an update as to further collaboration with VCU in the month ahead.
AEA loaded into Z-pods™ (Lupus)
Developed in partnership with Zylö Therapeutics, Hoth’s AEZ-loaded Z-pods™ are currently being tested for approval in the treatment of Cutaneous Lupus Erythematosus (CLE). Scientists have demonstrated that topical administration with AEA-loaded nanoparticles significantly prevents the development of CLE in an established animal model of lupus.
Exon Skipping Approach (Allergic Disease)
During Q4 of 2019, Hoth entered into a licensing agreement with North Carolina State University (NC State) to study NC State’s Exon Skipping Approach for Treating Allergic Diseases. This Exon Skipping Approach was developed by Dr. Glenn Cruse, Principal Investigator and Assistant Professor in the Department of Molecular Biomedical Sciences at the NC State College of Veterinary Medicine. During Dr. Cruse’s research, a new approach for the technique of antisense oligonucleotide-mediated exon skipping to specifically target and down-regulate IgE receptor expression in mast cells was identified. Through this collaborative project, NCSU looks to establish the most effective approach for targeting genes that regulate surface expression of FcεRI in mast cells that mediate allergic airway inflammation.
About Hoth Therapeutics, Inc.
Hoth Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing new generation therapies for dermatological disorders. Hoth’s pipeline has the potential to improve the quality of life for patients suffering from indications including atopic dermatitis, chronic wounds, psoriasis, asthma and acne. Hoth has recently entered into a Joint Development Agreement to further the development of vaccine prospects to prevent, intercept or treat the Coronavirus (COVID-19) based upon VaxCelerate, a self-assembling vaccine (SAV) platform exclusively licensed by Voltron from the Vaccine and Immunotherapy Center (VIC) at Massachusetts General Hospital (MGH). To learn more, please visit www.hoththerapeutics.com.
Forward Looking Statements
This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release include, but are not limited to, statements that relate to the advancement and development of AEA-loaded Z-pods™, the commencement of clinical trials, the availability of data from clinical trials and other information that is not historical information. When used herein, words such as “anticipate”, “being”, “will”, “plan”, “may”, “continue”, and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Hoth’s current expectations and various assumptions. Hoth believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Hoth may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation, market conditions and the factors described under the caption “Risk Factors” in Hoth’s Form 10K for the period ending December 31, 2018, and Hoth’s other filings made with the Securities and Exchange Commission. Consequently, forward-looking statements should be regarded solely as Hoth’s current plans, estimates and beliefs. Investors should not place undue reliance on forward-looking statements. Hoth cannot guarantee future results, events, levels of activity, performance or achievements. Hoth does not undertake and specifically declines any obligation to update, republish, or revise any forward-looking statements to reflect new information, future events or circumstances or to reflect the occurrences of unanticipated events, except as may be required by law.
Investor Contact:
Phone: (646) 756-2997
Email: investorrelations@hoththerapeutics.com
www.hoththerapeutics.com
KCSA Strategic Communications
Valter Pinto, Managing Director
(212) 896-1254
Hoth@kcsa.com
Source: Hoth Therapeutics, Inc.
New York, NY – November 14, 2019 – Hoth Therapeutics, Inc. (NASDAQ: HOTH) (“HOTH” or the “Company”), a biopharmaceutical company focused on developing new generation therapies for dermatological disorders such as atopic dermatitis, chronic wounds, psoriasis and acne, today announced, in partnership with the George Washington University (GW), the initiation of a preclinical study of Aprepitant for dermatological treatment relating to the side effects of cancer medication.
In July 2019, HOTH and GW announced its working relationship and entering into an exclusive license option agreement pertaining to its intellectual property on the use of Aprepitant in treating skin-related and other side effects from drugs used to treat cancer. Traditionally, Aprepitant is utilized along with other medications to help prevent nausea and vomiting caused by cancer drug treatment chemotherapy by blocking the cause and one of the body’s natural substances, neurokinin-1.
Mr. Robb Knie, CEO of Hoth Therapeutics, commented, “Initial findings by our team and GW on the positive dermatological effects of Aprepitant in cancer patients have been fascinating. We are pleased today to launch this study to continue our exploration of this possible treatment. Hoth looks forward to our initial data read-out and further testing with our partners at the George Washington University.”
Under the terms of the agreement, HOTH has the option to exclusively license two U.S. patents covering methods of using Aprepitant and other drugs that inhibit this neurokinin-1 function. Based on early data findings from HOTH and GW, this preclinical study is being initiated to continue exploring the dermatological benefits of Aprepitant in cancer patients who receive chemotherapy.
About Hoth Therapeutics, Inc.
Hoth Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing new generation therapies for dermatological disorders. HOTH’s pipeline has the potential to improve the quality of life for patients suffering from indications including atopic dermatitis, chronic wounds, psoriasis, and acne. HOTH has the exclusive worldwide rights to BioLexa, the company’s proprietary lead drug candidate topical platform that uniquely combines two FDA approved compounds to fight bacterial infections across multiple indications. HOTH is preparing to launch its clinical trial for the treatment of adolescent subjects, 2-17 years of age, with mild to moderate atopic dermatitis during 2020. To learn more, please visit www.hoththerapeutics.com.
Forward Looking Statements
This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release include, but are not limited to, statements that relate to the advancement and development of the BioLexa Platform, the commencement of clinical trials, the availability of data from clinical trials and other information that is not historical information. When used herein, words such as “anticipate”, “being”, “will”, “plan”, “may”, “continue”, and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon HOTH’s current expectations and various assumptions. HOTH believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. HOTH may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation, market conditions and the factors described under the caption “Risk Factors” in HOTH’s Form 10K for the period ending December 31, 2018, and HOTH’s other filings made with the Securities and Exchange Commission. Consequently, forward-looking statements should be regarded solely as HOTH’s current plans, estimates and beliefs. Investors should not place undue reliance on forward-looking statements. HOTH cannot guarantee future results, events, levels of activity, performance or achievements. HOTH does not undertake and specifically declines any obligation to update, republish, or revise any forward-looking statements to reflect new information, future events or circumstances or to reflect the occurrences of unanticipated events, except as may be required by law.
Contacts
Investor Relations Contact:
Phone: (646) 756-2997
Email: investorrelations@hoththerapeutics.com
www.hoththerapeutics.com
KCSA Strategic Communications
Valter Pinto / Daniela Guerrero
(212) 896-1254 / (212) 682-6300
Hoth@kcsa.com
SOURCE Hoth Therapeutics, Inc.
New York, NY – November. 6, 2019 – Hoth Therapeutics, Inc. (NASDAQ: HOTH) (“HOTH” or the “Company”), a biopharmaceutical company focused on unique targeted therapeutics for patients suffering from indications such as atopic dermatitis–also known as eczema–as well as dermatological and chronic wound disorders, today announced initiating a Phase 1 confirmatory study, related to their proprietary AEA-loaded Z-pods™ in the treatment of Cutaneous Lupus Erythematosus [CLE], a chronic autoimmune disease that affects the skin.
The study is being conducted in partnership with Zylö Therapeutics to confirm that topical administration of Hoth’s AEA-loaded Z-pods™ inhibits the development of CLE lesions in a well-established animal model of lupus. Test protocol requires weekly scoring and a treatment period of 10 weeks after the initial lesions are recorded. The trials are piloted by Jackson Laboratory, an independent, nonprofit biomedical research institution.
“Commencing this confirmation study is an important step toward underlining the transformative potential of AEA-loaded Z-pods™ in patients suffering from Cutaneous Lupus Erythematosus,” stated Mr. Robb Knie, CEO of Hoth Therapeutics, Inc. “We are pleased with the progress we have made in the development of our lupus treatment since announcing our strategy earlier this year with our partner Zylö Therapeutics. Management looks forward to reporting key findings with the completion of this study, which we expect will provide a critical point of validation for our proprietary topical solution.”
Hoth owns an exclusive license to develop Anandamide-loaded Z-pods™ for the treatment of CLE in North America. Anandamide, generally referred to as AEA, is one of the cannabinoids that the human body makes naturally. The Company also possesses rights related to geographic expansion and to follow-on indications such as psoriasis and rheumatoid arthritis.
About Hoth Therapeutics, Inc.
Hoth Therapeutics, Inc., a Nevada corporation, is a biopharmaceutical company focused on unique targeted therapeutics for patients suffering from indications such as atopic dermatitis, also known as eczema. Hoth has exclusive worldwide rights to the BioLexa Platform.
Forward Looking Statements
This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release include, but are not limited to, statements that relate to the advancement and development of the BioLexa Platform, the commencement of clinical trials, the availability of data from clinical trials and other information that is not historical information. When used herein, words such as “anticipate”, “being”, “will”, “plan”, “may”, “continue”, and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Hoth’s current expectations and various assumptions. Hoth believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Hoth may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation, market conditions and the factors described under the caption “Risk Factors” in Hoth’s Form 10K for the period ending December 31, 2018, and Hoth’s other filings made with the Securities and Exchange Commission. Consequently, forward-looking statements should be regarded solely as Hoth’s current plans, estimates and beliefs. Investors should not place undue reliance on forward-looking statements. Hoth cannot guarantee future results, events, levels of activity, performance or achievements. Hoth does not undertake and specifically declines any obligation to update, republish, or revise any forward-looking statements to reflect new information, future events or circumstances or to reflect the occurrences of unanticipated events, except as may be required by law.
Contacts
Investor Relations Contact:
Phone: (646) 756-2997
Email: investorrelations@hoththerapeutics.com
www.hoththerapeutics.com
KCSA Strategic Communications
Valter Pinto / Daniela Guerrero
(212) 896-1254 / (212) 682-6300
Source: Hoth Therapeutics, Inc.
New York, NY – July 22, 2019 – Hoth Therapeutics, Inc. (NASDAQ: HOTH), a development stage biopharmaceutical company focused on unique targeted therapeutics for patients suffering from indications such as atopic dermatitis–also known as eczema–as well as dermatological and chronic wound disorders, today announced initial results of its Pilot Study of BioLexa application on diabetic skin ulcers.
This pilot study was designed to establish foundational protocols for assessing effectiveness of a therapeutic compound developed by Hoth Therapeutics, the BioLexa Platform, for accelerating and improving wound healing in the context of acute and chronic diabetic ulcers, using an animal model of impaired wound healing developed at Massachusetts General Hospital (MGH).
Specific study objectives were:
- Optimize the method of application of the therapeutic compound (BioLexa) on diabetic skin wounds in the mouse models of acute and chronic diabetic wound healing established at the Vaccine and Immunotherapy Center (VIC) at MGH directed by Dr. Mark Poznansky.
- Optimize the Staphylococcus aureus inoculation dose to achieve biofilm growth in the infected diabetic wound model.
An animal protocol amendment was submitted to and approved by the MGH Institutional Animal Care and Use Committee (IACUC) to allow the application of the BioLexa compound on wounds in the established mouse model
A full Biosafety protocol was submitted to and approved by the Partners Institutional Biosafety Committee (IBC) to allow the use of pathogens such as S. aureus.
All work was performed in compliance with these institutionally approved protocols.
After 22 days post-injury, the animals were euthanized and the dressings on the wounds were removed to reveal the wounds and collect tissue biopsies.
Upon removal of the wound dressings and the obscuring cream, Dr. Ruxandra Sirbulescu who designed and conducted the pilot study at MGH observed that the majority of the wounds, treated with either BioLexa or the carrier base control of BioLexa, were fully closed and re-epithelialized. While the present pilot study did not include wounds treated with saline solution, previous studies in this model have shown that wounds treated with control solutions, such as saline, remain fully open ulcers at 22 days post injury (Sirbulescu et al., 2017, Wound Repair Regen.).
Dr Sirbulescu remarked “We observed complete closure in all treated wounds, which is not typical for this experimental model. Moreover, several parameters associated with the quality of tissue regeneration were significantly improved after treatment of the open ulcers with Biolexa, including better collagen deposition and increased angiogenesis. Our next studies will aim to confirm the observed regenerative effects of the Biolexa platform in the context of chronic diabetic ulcers, with and without substantial bacterial burden.”
Robb Knie, CEO of Hoth commented “Preliminary results indicated that, as a wound care product, Biolexa performed extremely well in a mouse model of diabetic ulcers. Hoth is excited about the next phase of our pilot program for DFU’s and look forward to sharing results upon the completion of the next module.”
Biopsies collected from all wounds were processed for histological evaluation. Tissue samples were sectioned transversally through the wound bed/scar, and the sections were stained with hematoxylin & eosin as well as Masson’s trichrome to evaluate tissue structure.
Example of longitudinal imaging of wounds in one representative animal (out of a total of 10). Over the course of 22 days the wounds remained covered. The cream compounds (either BioLexa or carrier control) were replenished on days 2 and 14. The treatment covered the wound bed and obscured the wound edges from view.
High-magnification detail of a section (stained with Masson’s trichrome) collected from a healed wound biopsy treated with BioLexa compound. Note the complete reepithelialization process and the re-forming of an epidermal and dermal layer, with multiple newly formed blood vessels (capillaries). Fibroblasts in the dermis actively deposit collagen (blue).
The tissue sections were scored according to criteria described in detail previously (Sirbulescu et al., 2017, Wound Repair Regen), for the following categories (Figure 5): Amount of granulation tissue; Collagen fiber orientation; Maturity of newly deposited collagen; Pattern of collagen deposition; Angiogenesis; Thickness of regenerated tissue; Width of scar; Cutaneous nerve growth.
Preliminary evaluation of the wound tissue biopsies at day 22 post injury and treatment with BioLexa or carrier control.
These preliminary data suggest a benefit of BioLexa treatment over placebo in certain categories. However, a larger, well-controlled study is required before any clear conclusion can be drawn on treatment efficacy.
About Hoth Therapeutics, Inc.
Hoth Therapeutics, Inc., a Nevada corporation, is a biopharmaceutical company focused on unique targeted therapeutics for patients suffering from indications such as atopic dermatitis, also known as eczema. Hoth has exclusive worldwide rights to the BioLexa Platform.
Forward Looking Statements
This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release include, but are not limited to, statements that relate to the advancement and development of the BioLexa Platform, the commencement of clinical trials, the availability of data from clinical trials and other information that is not historical information. When used herein, words such as “anticipate”, “being”, “will”, “plan”, “may”, “continue”, and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Hoth’s current expectations and various assumptions. Hoth believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Hoth may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation, market conditions and the factors described under the caption “Risk Factors” in Hoth’s Form 10K for the period ending December 31, 2018, and Hoth’s other filings made with the Securities and Exchange Commission. Consequently, forward-looking statements should be regarded solely as Hoth’s current plans, estimates and beliefs. Investors should not place undue reliance on forward-looking statements. Hoth cannot guarantee future results, events, levels of activity, performance or achievements. Hoth does not undertake and specifically declines any obligation to update, republish, or revise any forward-looking statements to reflect new information, future events or circumstances or to reflect the occurrences of unanticipated events, except as may be required by law.
Contact
Investor Relations Contact:
Phone: (646) 756-2997
Email: investorrelations@hoththerapeutics.com
www.hoththerapeutics.com
Company analyzing efficacy of Aprepitant, in reducing skin-related disorders attributed to cancer treatment
New York, NY – June 28, 2019 – Hoth Therapeutics, Inc. (NASDAQ: HOTH), a biopharmaceutical company focused on unique targeted therapeutics for patients suffering from indications such as atopic dermatitis–also known as eczema–as well as dermatological and chronic wound disorders, today announced that its has entered into a sponsored research agreement with George Washington University to explore the potential use of Aprepitant for topical and/or systemic therapy to counter the dermatological related side-effects of Erlotinib.
Erlotinib is a drug that used to combat various cancers. The treatment has been known to cause varying degrees of skin rashes, lesions, hair loss and nail changes to patients. These side-effects can impact the patient’s quality of life and even cause treatment interruption, jeopardizing the overall success of the treatment. The research agreement intends to show that other chronic conditions, displaying dermatitis, may benefit from this novel therapeutic approach. Overseeing this collaboration will be Dr. William B Weglicki, Ph.D., Professor of Biochemistry and Molecular Medicine and Professor of Medicine (Secondary).
“Hoth is thrilled to partner with George Washington University, as we research treatments to improve the quality of life of patients that are undergoing life saving treatments,” stated, Mr. Robb Knie, CEO of Hoth Therapeutics. “We couldn’t ask for a better partner on the Aprepitant project. We have already begun collaborating with Dr. Weglicki, and his team, and their expertise is immediately evident. We look forward to working with such a talented group and will announce our first study at George Washington University in the coming weeks.”
Dr. Weglicki commented, “My team and I look forward to determining the efficacy of this promising new compound in targeting both mild and severe cutaneous toxicity. Transitioning to a modern culture of research, one which expands beyond the university into collaboration with innovative companies like Hoth Is paramount for as at GWU. This is an opportunity to not only improve the overall wellness of those undergoing cancer treatments, but the millions of people that are afflicted with dermatological disorders.”
About Hoth Therapeutics, Inc.
Hoth Therapeutics, Inc., a Nevada corporation, is a biopharmaceutical company focused on unique targeted therapeutics for patients suffering from indications such as atopic dermatitis, also known as eczema. Hoth has exclusive worldwide rights to the BioLexa Platform.
Forward Looking Statements
This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release include, but are not limited to, statements that relate to the advancement and development of the BioLexa Platform, the commencement of clinical trials, the availability of data from clinical trials and other information that is not historical information. When used herein, words such as “anticipate”, “being”, “will”, “plan”, “may”, “continue”, and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Hoth’s current expectations and various assumptions. Hoth believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Hoth may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation, market conditions and the factors described under the caption “Risk Factors” in Hoth’s Form 10K for the period ending December 31, 2018, and Hoth’s other filings made with the Securities and Exchange Commission. Consequently, forward-looking statements should be regarded solely as Hoth’s current plans, estimates and beliefs. Investors should not place undue reliance on forward-looking statements. Hoth cannot guarantee future results, events, levels of activity, performance or achievements. Hoth does not undertake and specifically declines any obligation to update, republish, or revise any forward-looking statements to reflect new information, future events or circumstances or to reflect the occurrences of unanticipated events, except as may be required by law.
Contact
Investor Relations Contact:
Phone: (646) 756-2997
Email: investorrelations@hoththerapeutics.com
www.hoththerapeutics.com
Source: Hoth Therapeutics, Inc.
New York, NY – June 11, 2019 – Hoth Therapeutics, Inc. (NASDAQ: HOTH), a biopharmaceutical company focused on unique targeted therapeutics for patients suffering from indications such as atopic dermatitis-also known as eczema-as well as dermatological and chronic wound disorders, announced the formation of its subsidiary, Hoth Therapeutics Australia Pty Ltd, in anticipation to perform clinical trials for atopic dermatitis.
Hoth Therapeutics Australia Pty Ltd will oversee the preparation and execution of Hoth’s first clinical trial, known as Efficacy and Safety of BioLexa for the Treatment of Mild-to-Moderate Atopic Dermatitis. The newly formed entity will also be eligible for a significant Research and Development tax rebate. The subsidiary will supervise data management, biostatistical, medical monitoring, quality insurance, regulatory and central laboratory services to support the trial.
“We are excited by the opportunity to work with Australian researchers and members of the international pharmaceutical industry, in regards to the development of our proprietary atopic dermatitis treatment,” stated Mr. Robb Knie, CEO of Hoth Therapeutics. “This endeavor is a significant milestone for us, as we move towards clinical trials. Hoth is committed to working diligently with physicians, and regulators in order to successfully pilot our BioLexa Platform to the millions of people that are afflicted with atopic dermatitis.”
The subsidiary was formed in connection with Novotech and CoSec Consulting. Headquartered in Australia since 1996 and operating in the Asia Pacific region, Novotech is internationally recognized in the industry as a leading regional full-service contract research organization. Cosec Consulting provides carefully crafted compliance, governance and financial solutions for offshore companies undertaking research and development activities in Australia.
About Hoth Therapeutics, Inc.
Hoth Therapeutics, Inc., a Nevada corporation, is a biopharmaceutical company focused on unique targeted therapeutics for patients suffering from indications such as atopic dermatitis, also known as eczema. Hoth has exclusive worldwide rights to the BioLexa Platform.
Forward Looking Statements
This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release include, but are not limited to, statements that relate to the advancement and development of the BioLexa Platform, the commencement of clinical trials, the availability of data from clinical trials and other information that is not historical information. When used herein, words such as “anticipate”, “being”, “will”, “plan”, “may”, “continue”, and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Hoth’s current expectations and various assumptions. Hoth believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Hoth may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation, market conditions and the factors described under the caption “Risk Factors” in Hoth’s Form 10K for the period ending December 31, 2018, and Hoth’s other filings made with the Securities and Exchange Commission. Consequently, forward-looking statements should be regarded solely as Hoth’s current plans, estimates and beliefs. Investors should not place undue reliance on forward-looking statements. Hoth cannot guarantee future results, events, levels of activity, performance or achievements. Hoth does not undertake and specifically declines any obligation to update, republish, or revise any forward-looking statements to reflect new information, future events or circumstances or to reflect the occurrences of unanticipated events, except as may be required by law.
Contact
Investor Relations Contact:
Phone: (646) 756-2997
Email: investorrelations@hoththerapeutics.com
www.hoththerapeutics.com
SOURCE Hoth Therapeutics, Inc.
New York, NY – June 10, 2019 – Hoth Therapeutics, Inc. (NASDAQ:HOTH), a biopharmaceutical company focused on unique targeted therapeutics for patients suffering from indications such as atopic dermatitis-also known as eczema-as well as dermatological and chronic wound disorders, today announced it has signed contracts with providers for production of their BioLexa therapeutic, in preparation for upcoming toxicology and clinical studies.
Hoth has begun preparations for the testing of its formulation for both active and vehicle stability. The Company has engaged the services of both Particle Sciences, Inc. and Regis Technologies, Inc., in order to fulfill the necessary formulation and production of both Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) of its biopharmaceutical. The BioLexa Platform is a proprietary, patented antimicrobial therapy designed for the treatment of atopic dermatitis. The therapeutic offers a non-corticosteroid approach treating atopic dermatitis.
“Management is extremely pleased to announce this significant step in our developmental track,” stated Robb Knie, CEO of Hoth Therapeutics. “Atopic dermatitis often has a negative impact on patients’ overall health and quality of life. Current treatments, such as topical corticosteroids and other treatments frequently carry harsh side effects. Hoth looks forward to initiating these clinical trials, as we believe that our BioLexa therapeutic has the potential to become a much needed treatment for this underserved market.”
About Hoth Therapeutics, Inc.
Hoth Therapeutics, Inc., a Nevada corporation, is a biopharmaceutical company focused on unique targeted therapeutics for patients suffering from indications such as atopic dermatitis, also known as eczema. Hoth has exclusive worldwide rights to the BioLexa Platform.
Forward Looking Statements
This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release include, but are not limited to, statements that relate to the advancement and development of the BioLexa Platform, the commencement of clinical trials, the availability of data from clinical trials and other information that is not historical information. When used herein, words such as “anticipate”, “being”, “will”, “plan”, “may”, “continue”, and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Hoth’s current expectations and various assumptions. Hoth believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Hoth may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation, market conditions and the factors described under the caption “Risk Factors” in Hoth’s Form 10K for the period ending December 31, 2018, and Hoth’s other filings made with the Securities and Exchange Commission. Consequently, forward-looking statements should be regarded solely as Hoth’s current plans, estimates and beliefs. Investors should not place undue reliance on forward-looking statements. Hoth cannot guarantee future results, events, levels of activity, performance or achievements. Hoth does not undertake and specifically declines any obligation to update, republish, or revise any forward-looking statements to reflect new information, future events or circumstances or to reflect the occurrences of unanticipated events, except as may be required by law.
Contact
Investor Relations Contact:
Phone: (646) 756-2997
Email: investorrelations@hoththerapeutics.com
www.hoththerapeutics.com
Amato and Partners, LLC
Investor Relations Counsel
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SOURCE Hoth Therapeutics Inc.
Hoth and Zylö to use new topical application of an endocannabinoid, anandamide (AEA), in nanoparticles
New York, NY – May 14, 2019 – Hoth Therapeutics, Inc. (Nasdaq: HOTH) a biopharmaceutical company focused on unique targeted therapeutics for patients suffering from indications such as atopic dermatitis–also known as eczema–as well as dermatological and chronic wound disorders, today announced that the company has signed a term sheet with Zylö Therapeutics Inc (Zylö) to co-develop a new treatment for patients suffering from Cutaneous Lupus Erythematosus (CLE). CLE is a chronic autoimmune disease that affects the skin.
Zylö, dedicated to bringing innovative technologies to multiple facets of medicine, has an innovative sustained-release drug-delivery system that was developed by Joel Friedman MD PhD, Adam Friedman MD FAAD, and Andrew Draganski PhD. The delivery system uses patented xerogel-derived nanoparticles, called Z-pods™, to deliver—in a sustained and controlled manner—notoriously hard-to-deliver therapeutic agents through topical administration. For more information, please visit; http://www.zylotherapeutics.com/
Scientists at Einstein College of Medicine recently demonstrated that topical administration with AEA-loaded nanoparticles significantly prevents the development of CLE in an established animal model of lupus. This work reinforces and highlights the utility of targeting the endocannabinoid system for autoimmune rheumatic diseases.
The work at Einstein supports the thesis that AEA loaded into Z-pods™ improves drug skin penetration, reduces the expected inflammatory cytokine secretion by keratinocytes when exposed to ultraviolet radiation, prevents the development of CLE skin lesions, improves skin histopathology, prevents inflammation and structural damage on histology and reduces macrophages and C3 accumulation.
According to estimates by the Lupus Foundation of America (LFA), 1.5 Million Americans currently suffer from lupus, with 16,000 new cases reported annually. Tragically, lupus strikes mostly women of child-bearing age. Worldwide, the LFA estimates that at least five million people may have some form of the disease. Of the people diagnosed, approximately two-thirds will develop CLE. The annual average cost to provide medical treatment for a person with lupus: $6,000 to $10,000, with some treatment costing several thousand dollars a month.
“Management is extremely pleased to partner with Zylö Therapeutics, enhancing our portfolio of unique treatments for patients suffering from various dermatological related ailments,” stated, Mr. Robb Knie, CEO of Hoth Therapeutics. “Zylö’s initial work shows significant promise in combating Cutaneous Lupus Erythematosus, and we look forward to working with them in order to bring this treatment to market.”
“We are thrilled to partner with Hoth, a company that is committed to innovative solutions and partnerships to develop treatments for diseases with a high unmet clinical need, such as lupus,” said Scott Pancoast, CEO of Zylö. “As we work with the Hoth team to advance AEA-loaded Z-pods through the next stages of development, we expect to further demonstrate the important role that our patented Z-pod delivery system plays in improving treatment outcomes.”
The term sheet is non-binding and neither party thereto shall have any obligation to consummate a transaction of any kind until such time as the parties have entered into a mutually agreeable definitive agreement. There can be no assurance that any such definitive agreement will be entered into or that the transaction will be completed on the terms set forth in the term sheet, or at all.
About Hoth Therapeutics, Inc.
Hoth Therapeutics, Inc., a Nevada corporation, is a biopharmaceutical company focused on unique targeted therapeutics for patients suffering from indications such as atopic dermatitis, also known as eczema. Hoth has exclusive worldwide rights to the BioLexa Platform.
Forward Looking Statements
This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release include, but are not limited to, statements that relate to the advancement and development of the BioLexa Platform, the commencement of clinical trials, the availability of data from clinical trials and other information that is not historical information. When used herein, words such as “anticipate”, “being”, “will”, “plan”, “may”, “continue”, and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Hoth’s current expectations and various assumptions. Hoth believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Hoth may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation, market conditions and the factors described under the caption “Risk Factors” in Hoth’s Form 10K for the period ending December 31, 2018, and Hoth’s other filings made with the Securities and Exchange Commission. Consequently, forward-looking statements should be regarded solely as Hoth’s current plans, estimates and beliefs. Investors should not place undue reliance on forward-looking statements. Hoth cannot guarantee future results, events, levels of activity, performance or achievements. Hoth does not undertake and specifically declines any obligation to update, republish, or revise any forward-looking statements to reflect new information, future events or circumstances or to reflect the occurrences of unanticipated events, except as may be required by law.
Contact
Investor Relations Contact:
Phone: (646) 756-2997
Email: investorrelations@hoththerapeutics.com
www.hoththerapeutics.com
SOURCE Hoth Therapeutics, Inc.
About Hoth Therapeutics
FOCUSING ON THE NEXT GENERATION OF THERAPEUTICS
OUR TECHNOLOGY IS BASED ON CUTTING-EDGE SCIENTIFIC RESEARCH FROM THE UNIVERSITY OF CINCINNATI.
Hoth Therapeutics is a development stage biopharmaceutical company focused on proprietary therapeutics for patients suffering from indications such as atopic dermatitis, also known as eczema. To treat indications impacting more than 32 million Americans, Hoth is working to develop and commercialize the BioLexa™ Platform, a proprietary, patented, drug compound platform developed at the University of Cincinnati. The BioLexa Platform has achieved positive results at preclinical studies conducted at the University of Miami.
BioLexa PlatformTM
Hoth Therapeutics is a development-stage biopharmaceutical company focused on unique targeted therapeutics for patients suffering from indications such as atopic dermatitis, also known as eczema.
Hoth owns the exclusive rights to develop the BioLexa PlatformTM for all indications in humans. The BioLexa PlatformTM is a proprietary, patented, drug compound platform developed at the University of Cincinnati. The BioLexa PlatformTM combines an FDA-approved zinc chelator with one or more approved antibiotics in a topical dosage form to address unchecked eczema flare-ups by preventing the formation of infectious biofilms and the resulting clogging of sweat ducts. It is the first product candidate intended to prevent the symptom-triggering flare-ups rather than simply treating symptoms after they occur.
We intend to explore the use of the BioLexa PlatformTM for the treatment of atopic dermatitis, or eczema.
We also intend to explore the use of the BioLexa PlatformTM in the aesthetic dermatology field to help treat and reduce post-procedure infections, accelerate healing and improve clinical outcomes for patients undergoing procedures. We believe that the BioLexa PlatformTM’s ability to fight bacterial growth will enable the innate immune system to focus on optimal healing rather than fighting post-procedure infection.
Finally, we intend to explore the use of the BioLexa PlatformTM in connection with diabetic foot ulcers. We believe that the BioLexa PlatformTM‘s ability to fight bacterial growth will help initiate and/or improve chronic diabetic wound healing as well as accelerate the healing of diabetic wounds with S. aureus.
Genetic Marker License
Hoth has also licensed exclusive rights to certain patented technology from the University of Cincinnati for use in determining the risk that a patient will develop allergies to peanuts, milk and other foods as well as predict propensity for eczema. Hoth’s overall goal is to develop and make ready for commercialization a family of genetic screening tests based on the licensed technology.
THE BIOLEXA PLATFORM
The BioLexa Platform is a proprietary, patented antimicrobial therapy.
The Platform is based on cutting-edge scientific research from Univ. of Cincinnati (PNAS 2008, PNAS 2013, Biochemical J. 2017, Protein Science 2017).
BACKGROUND:
Centers for Disease Control data indicates that “biofilms” are implicated in over 2/3 of all skin infections. Biofilms are specialized bacterial colonies that are resistant to antibiotics and immune system responses. Moreover, staph bacteria require zinc to form the biofilms that allow the bacterial colonies to grow and resist treatment.
The BioLexa Platform is a synergistic combination of a zinc chelator and an antibiotic that prevents biofilms from forming, leaving the bacteria susceptible to elimination by the antibiotic.
BACTERIAL BIOFILMS: A MAJOR CHALLENGE
Biofilms are specialized colonies of bacteria that adhere to a surface and to one another. The bacteria growing in a biofilm are highly resistant to antibiotics and immune responses. As a result staph biofilms cause recurrent, hard to treat infections.
ZINC & STAPH BIOFILMS
Zinc is required for the formation of staph biofilms
The Staph biofilms form when thread-like thread-like proteins (Aap or SasG) on the bacterial surface stick to one another holding the cells together. The Herr Lab, run by Dr. Andrew Herr at the University of Cincinnati discovered that these proteins only become adhesive when exposed to zinc ions.
The BioLexa Platform traps all the zinc ions by adding a chelator called DTPA, which prevents Staph biofilm formation. In pre-clinical testing on animals, the BioLexa Platform showed impactful results.
FDA APPROVAL
HOTH THERAPEUTICS INTENDS TO PURSUE A 505(B)(2) REGULATORY PATHWAY.
FDA APPROVAL
The FDA allows some of the safety and efficacy information on active ingredients(s) to come from studies not conducted by Hoth. Because Hoth can rely on the historical data, we should have a much shorter time and cost to get BioLexa FDA approved, as compared to standard 505(B)(1) approval.
Source: https://hoththerapeutics.com/
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