Hoth Therapeutics completes pre-IND meeting with FDA on HT-KIT in cancer

Hoth Therapeutics announced the successful completion of a pre-IND meeting with the FDA regarding the company’s development plan for its HT-KIT therapeutic. 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. 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 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. The purpose of the requested meeting was to gain the Agency’s agreement on the suitability the 505(b) 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.