Biopharmaceutical company Hoth Therapeutics, Inc. (HOTH) announced Monday it has submitted a request for a Pre-Investigational New Drug (IND) meeting to the U.S. Food and Drug Administration (FDA) to discuss the proposed drug development program for HT-KIT, a new molecular entity, for the treatment of advance systemic mastocytosis (AdvSM), a rare aggressive form of cancer.
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.
Currently in the preclinical stage of development of HT-KIT, Hoth anticipates a meeting with the FDA to be scheduled during the fourth quarter of 2023.
During the pre-IND meeting with the FDA, Hoth Therapeutics plans to discuss the overall proposed drug development program for HT-KIT including requirements for nonclinical, clinical pharmacology, clinical, chemistry, and manufacturing controls.
Hoth also plans to present clinical trial designs for the IND-opening, phase 1 dose ranging and dose extension studies as well as a proposed follow-up phase 2 safety and efficacy study; both studies will be conducted in adult patients with advanced systemic mastocytosis (AdvSM).
AdvSM includes patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SMAHN), and mast cell leukemia (MCL).
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