Hoth Therapeutics granted Pre-IND meeting for HT-KIT by FDA

Hoth Therapeutics announced the Pre-IND meeting requested on September 8th for HT-KIT with the U.S. FDA has been granted to receive written responses only from the FDA that are targeted for delivery on November 7, 2023. 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. The Pre-IND meeting topics include the acceptability of the overall proposed drug development program for HT-KIT including requirements for nonclinical, clinical pharmacology, clinical, chemistry, and manufacturing controls. The proposed clinical trial designs for the first clinical studies in the HT-KIT program are also included in the Pre-IND meeting topics to receive FDA feedback.