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Retinoids, which include Vitamin A (retinol) and its analogues (both synthetic and metabolites), play a critical role in cell signaling and biological processes, including regulation of immune cells and inflammation, signaling pathways that control normal skin maintenance, embryonic development, and cell growth/differentiation/repair. Deficiencies in retinoids and their active metabolites have been implicated in a wide variety of diseases. In the skin, retinol deficiency leads to hyperkeratosis and keratinizing metaplasia that is observed in skin disorders like psoriasis and acne. Vitamin A and retinoic acid also play a crucial role in regulating cell proliferation, differentiation, and apoptosis and therefore, altered metabolism of retinoids has been suspected as a potential role in tumorigenesis. Accordingly, retinoids have been approved in the US for treatment of acne and psoriasis as well as other therapeutic indications (such as acute promyelocytic leukemia and cutaneous T-cell lymphoma); however, the therapeutic use of exogenous retinoids has been limited due to negative effects associated with high systemic concentrations.

A new therapeutic approach to increase intracellular retinoic acid (the active metabolite of retinol) potentially without causing negative side effects of exogenous retinoic acid is to use inhibitors of retinoic acid metabolism (collectively called RAMBAs), which prolong the presence of retinoic acid.

HT-003 is being developed as platform of RAMBAs for a broad spectrum of indications with underlying inflammation as the root cause. These variations include:

HT-003D is a novel RAMBA under investigation for topical treatment in acne and psoriasis applications.

HT-003IB is under investigation for the treatment of inflammatory bowel diseases, such as Crohn’s and Ulcerative Colitis.

Development Status

HT-003D is currently in the late preclinical stages of development.

In January 2021, Hoth Therapeutics expanded its research collaboration agreement with Weill Cornell Medicine to further understand the therapeutic mechanism of HT-003D for treatment of acne and other inflammatory skin diseases. The research will also explore safety of HT-003D in murine models. Dr. Jonathan Zippin, M.D., Ph.D., FAAD, Associate Professor of Dermatology at Weill Cornell Medicine and HOTH Senior Scientific Advisor, is the Principal Investigator for the research collaboration.

Upcoming Milestones
Hoth expects study results from Weill Cornell in Q3 2021 and is planning to begin formulation development prior to the end of 2021.

HT-003IB is currently in the early preclinical stages of development.

In March 2021, Hoth entered into a research agreement with REPROCELL Ltd. to assess the effect of the HT-003IB therapeutic platform on tissue from ulcerative colitis and Crohn’s disease patients. Fresh explants of ulcerative colitis and Crohn’s disease tissues obtained from surgical resection will be used as the test systems to investigate the therapeutic potential of the HT-003IB drugs via measurement of key biomarkers for these diseases.

Upcoming Milestones
Hoth expects to receive preliminary proof of concept study results in Q2 2021.