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Hoth Therapeutics Announces Successful Completion of Pre-IND Meeting with FDA Regarding Proposed Development of HT-001 For Cancer Patients
Hoth intends to pursue FDA Expedited Programs, such as Breakthrough Designation, pending generation of future clinical study data for HT-001 NEW YORK, Feb.
About this update from Hoth Therapeutics, Inc.
[{"type":"text","content":"Hoth intends to pursue FDA Expedited Programs, such as Breakthrough Designation, pending generation of future clinical study data for HT-001\n\n\nNEW YORK, Feb. 23, 2021 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a biopharmaceutical company, today announced today the successful completion of a pre-IND meeting with the U.S. Food and Drug Administration (FDA) regarding the Company's development plan for their HT-001 product. The Pre-IND meeting was completed through written responses provided by the FDA Division of Dermatology and Dentistry on February 22, 2021.\n\n \n \n \n \n \n \n\n \nHT-001 is a topical formulation under development for the treatment of rash and skin disorders associated with initial and repeat courses of tyrosine kinase inhibitor/epidermal growth factor receptor (EGFR) inhibitor therapy. HT-001 is being developed for New Drug Application (NDA) submission via the 505(b)(2) regulatory pathway.\nBased on the FDA's feedback, Hoth intends to advance its IND-enabling activities for HT-001 as planned. Key feedback from FDA provided as part of the Pre-IND written responses included:\nThe proposed HT-001 formulation and drug substance specifications are reasonable. No significant changes to the planned IND-enabling toxicology program for the planned phase 2a study The proposed indication for HT-001 across the entire class of EGFR inhibitors may be appropriate, pending appropriate data from phase 3 trials. Signs and symptoms related to EGFR inhibitor therapy could qualify as a \"serious condition\" that could enable future application for programs under the FDA guidance, Expedited Programs for Serious Conditions such as Breakthrough Designation; this is also pending the development of preliminary clinical evidence to support such applications. Detailed feedback regarding the design and assessments in the proposed IND-opening phase 2a study in patients receiving EGFR inhibitor therapy.\"We are very pleased with the outcome of the pre-IND meeting written responses from the FDA,\" said Robb Knie, CEO of Hoth Therapeutics. \"The positive feedback from the FDA is a significant milestone for Hoth in executing our clinical development program for HT-001 in treating cancer patients suffering from dermatological ailments during EGFR inhibitor treatment.\"\nAbout Hoth Therapeutics, Inc.\nHoth Therapeutics, Inc. is a...