Inhibitor Therapeutics Updates Clinical Development Plan

TAMPA, Fla., Aug. 22, 2024 – Inhibitor Therapeutics, Inc. (OTCQB: INTI) has announced significant progress in the development of its itraconazole formulation for treating Basal Cell Carcinomas (BCC) in patients with Basal Cell Carcinoma Nevus Syndrome (Gorlin Syndrome). The company is collaborating with The Gorlin Syndrome Alliance and consulting with its Scientific Advisory Board to expedite the approval process by the U.S. Food and Drug Administration (FDA).

Inhibitor has taken a major step by submitting a Pre-Investigational New Drug (PIND) application, which has been reviewed by the FDA’s Division of Dermatology and Dentistry. Additionally, input from the Division of Oncology 3 will be incorporated as needed. The FDA has provided preliminary comments to guide Inhibitor as it prepares its Investigational New Drug (IND) application.

The company has engaged Avior Bio to develop a new proprietary and patentable formulation of itraconazole. This new formulation will be bridged to the one used in Inhibitor’s completed clinical study, as well as to the generic formulation of itraconazole, through a pharmacokinetic (PK) study. Itraconazole is known for its safety profile and has demonstrated significant efficacy in treating BCC in Gorlin Syndrome patients, according to data from a previous clinical study.

The clinical study examined 477 targeted tumors. Results showed that 399 tumors reduced in size, 64 remained unchanged, and 14 increased. A clinically meaningful reduction of 30% or greater was observed in 275 (57.7%) of the tumors, with 130 tumors (27.3%) resolving completely.

Inhibitor’s future plans for developing its itraconazole therapeutic include completing the new proprietary formulation, conducting the bridging PK study, and preparing and submitting the IND. The company aims to submit the IND to the FDA for review by the end of the first quarter of 2025.