Research & Development
Hoth Therapeutics advances HT-KIT cancer treatment with FDA Pre-IND submission
11 September 2023 -

Biopharmaceutical company Hoth Therapeutics Inc (NASDAQ: HOTH) announced on Monday that it has submitted a request for a Pre-Investigational New Drug (Pre-IND) meeting with the U.S. Food and Drug Administration (FDA) for its cancer treatment HT-KIT, an antisense oligonucleotide targeting the cKIT proto-oncogene.

HT-KIT has received FDA Orphan Drug Designation and the company is in the preclinical development stage for HT-KIT. It anticipates an FDA meeting in Q4 2023 to discuss the drug development program, including nonclinical, clinical pharmacology and manufacturing requirements.

Hoth Therapeutics plans to present clinical trial designs for phase 1 and phase 2 studies of HT-KIT, focusing on adult patients with advanced systemic mastocytosis (AdvSM), a rare and aggressive cancer group. AdvSM includes conditions like aggressive systemic mastocytosis (ASM) and mast cell leukemia (MCL).

HT-KIT is designed to treat mast cell-derived cancers and anaphylaxis. It targets the KIT receptor tyrosine kinase, crucial for the survival and growth of mast cells, often associated with various human cancers. Hoth Therapeutics initially aims to address mast cell neoplasms, a rare and severe cancer type with limited treatment options.

FDA Orphan Drug Designation provides Hoth Therapeutics benefits such as assistance in the development process, clinical cost tax credits, fee exemptions, and seven years of post-approval marketing exclusivity.