Research & Development
Hoth Therapeutics requests FDA meeting to develop HT-KIT
12 September 2023 -

Hoth Therapeutics, Inc. (NASDAQ: HOTH), a patient-focused biopharmaceutical company, announced on Monday that the US Food and Drug Administration (FDA) has received a request for a Pre-Investigational New Drug (IND) meeting to discuss the planned drug development program for HT-KIT, a new molecular entity for treating advance systemic mastocytosis (AdvSM).

HT-KIT, an antisense oligonucleotide, is aimed at the proto-oncogene cKIT by inducing mRNA frame shifting and has received FDA's Orphan Drug Designation.

The product is currently in the preclinical stage. A meeting with the FDA is to be scheduled during the fourth quarter of 2023, wherein the company is planning to discuss the overall proposed drug development programme for HT-KIT including needs for nonclinical, clinical pharmacology, clinical, chemistry, and manufacturing controls.

Robb Knie, Chairman and CEO of Hoth Therapeutics, said, '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. We look forward to working closely with the FDA and advancing HT-KIT through the IND-enabling and clinical phases of development.'