Hoth reports FDA accepts Pre-IND submission for HT-KIT

Hoth Therapeutics announced it has submitted a request for a Pre-Investigational New Drug, or Pre-IND, meeting to the U.S. Food and Drug Administration to discuss the proposed drug development program for HT-KIT, a new molecular entity, for the treatment of advance systemic mastocytosis, or AdvSM. 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. “Today’s FDA submission brings us one step closer to advancing HT-KIT for patients who are suffering with a rare aggressive form of cancer,” stated Robb Knie, Chairman and CEO of Hoth Therapeutics. “We look forward to working closely with the FDA and advancing HT-KIT through the IND-enabling and clinical phases of development.”