Hoth Therapeutics, Inc. Announces Positive Results From Pilot Study of BioLexa on Diabetic Skin Ulcers

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:


  1. 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.
  2. 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.



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