Benzinga | Feb 23, 2021 08:04AM EST

Hoth Therapeutics Reports Successful Completion Of Pre-Investigational New Drug Application Meeting With FDA Related To Proposed Development Of HT-001 For Cancer Patients

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.

(PRNewsfoto/Hoth Therapeutics Inc.)

HT-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.

Based 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:

The 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."