Hoth Therapeutics to Initiate IND Enabling Studies of HT-001 Treatment for Cancer Patients

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[{"type":"text","content":"NEW YORK, Jan. 11, 2021 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a biopharmaceutical company, today announced an agreement with Charles River Laboratories to initiate preclinical studies of HT-001, a topical formulation designed for the treatment of patients with rash and skin disorders associated with initial and repeat EGFR inhibitor cancer treatment. \nTogether with Charles River Laboratories, Hoth has outlined six preclinical studies, the first bioanalytical method development studies beginning in Q1 2021. The initial studies will develop the required bioanalytical methods to perform GLP toxicology studies required by the U.S. Food and Drug Administration (FDA) to initiate clinical studies for HT-001. Hoth recently submitted a request for a Pre-Investigational New Drug (IND) meeting to the FDA to discuss the proposed drug development program of HT-001 which is also anticipated to occur during the first quarter of 2021. At the Pre-IND Meeting, Hoth will discuss the required preclinical safety and toxicology studies and the full development plan of HT-001. After the Meeting, Hoth will then initiate the GLP toxicology studies with Charles River Laboratories. \n\"We are pleased to have reached an agreement to initiate our studies in collaboration with Charles River Laboratories,\" said Robb Knie, CEO of Hoth Therapeutics. \"Charles River is the gold standard for toxicology studies in the industry. Execution of these critical preclinical studies takes us one step closer to the clinic. We believe our topical treatment addresses a significant unmet need as a supportive care treatment for the millions currently suffering from dermatological adverse effects of EGFR inhibitor cancer treatment.\"\nAbout 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 also recently entered into two different agreements to further the development of two different therapeutic prospects to prevent or treat COVID-19. To learn more, please visit www.hoththerapeutics.com.\nForward-Looking StatementThis press release includes forward-looking ...

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