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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
admin@amatoandpartners.com
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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