Hoth Therapeutics Announces Successful Completion of Pre-IND Meeting with FDA Regarding Development of Hoth’s Cancer Fighting HT-KIT

On November 14, 2023 Hoth Therapeutics, Inc. (NASDAQ: HOTH), a biopharmaceutical company, reported the successful completion of a pre-IND meeting with the U.S. Food and Drug Administration (FDA) regarding the Company’s development plan for its HT-KIT therapeutic (Press release, Hoth Therapeutics, NOV 14, 2023, View Source [SID1234637668]). The Pre-IND meeting was completed through written responses provided by the FDA Nonmalignant Hematology Division of Regulatory Operations for Cardiology, Hematology, Endocrinology, and Nephrology.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

HT-KIT is an antisense oligonucleotide that targets the proto-oncogene cKIT by inducing mRNA frame shifting and already has Orphan Drug Designation from the FDA.

Hoth Therapeutics, Inc., is developing the drug product HT-KIT indicated for the treatment of adult patients with AdvSM. HT-KIT is a single-strand phosphorodiamidate morpholino oligonucleotide (PMO).

The purpose of the requested meeting was to gain the Agency’s agreement on the suitability the 505(b)(1) regulatory pathway for approval of HT-KIT; adequacy of referenced nonclinical information and the proposed drug development plan to support opening the IND; and to discuss any filing issues the Agency may have with the proposed product.

The Sponsor was granted Orphan Drug Designation for HT-KIT for the treatment of mastocytosis.

Based on the FDA’s feedback, Hoth intends to advance its IND-enabling activities for HT-KIT as planned.

"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 development of HT-KIT and one step closer to getting this exciting cancer fighting therapeutic into the clinic and ready for the patients who would benefit the most."