Inhibitor Therapeutics, Inc. (OTCQB: INTI) develops an itraconazole-based treatment program for basal cell carcinomas in Basal Cell Carcinoma Nevus Syndrome, also known as Gorlin Syndrome. Company updates center on pharmacokinetic, safety and tolerability work, formulation development intended to address itraconazole solubility and absorption, and regulatory planning under the FDA's 505(b)(2) pathway.
Recurring developments also include intellectual-property and licensing activity, including an exclusive worldwide Johns Hopkins University license covering itraconazole as an angiogenesis-inhibiting active pharmaceutical ingredient for specified oncology fields. Other updates describe collaboration with Avior Bio, Scientific Advisory Board review of the Phase 2b SCORING trial, and clinical data from targeted basal cell carcinoma lesions.
Inhibitor Therapeutics (INTI) outlined recent regulatory, clinical, formulation, IP and legal developments and reminded stockholders of its September 15, 2026 virtual annual meeting.
In BCCNS, the company is proposing surgically eligible basal cell carcinomas as the primary efficacy endpoint and reported descriptive Phase IIb HP2001 data: 258 baseline surgically eligible tumors showed 52.7% objective responses, 87.2% control and a mean 40.4% reduction in longest diameter. New surgically eligible tumors occurred at 0.265 per patient-year over 37.77 patient-years, compared with approximately 2 on vismodegib and 29 on placebo in the separate Tang study. Adverse-event-related discontinuation in HP2001 was 13.2% over a median 7 months. The FDA has classified a requested meeting as Type C and plans written responses by end-September 2026.
The company reported ITZ101 75 mg exposure comparable to TOLSURA 65 mg, filed a U.S. provisional patent on its formulation, highlighted orphan designation, presented an internal peak U.S. revenue model of $178–$222 million and obtained a $3.0 million default judgment plus fees and interest in Delaware court.
Inhibitor Therapeutics (OTCQB: INTI) updated clinical, formulation and IP progress for its itraconazole program targeting surgically eligible basal cell carcinomas in Gorlin Syndrome.
The comparative PK three-way crossover study in Malaysia is mid-course, with Period 2 on April 10, 2026, Period 3 on April 24, 2026, and final PK sampling expected shipped for bioanalysis on or about May 1, 2026. Top-line comparative PK and relative bioavailability results are expected ahead of the final Clinical Study Report. The company highlighted a proprietary amorphous formulation to improve itraconazole solubility and plans a new global patent filing to expand IP around the formulation.
Inhibitor Therapeutics, Inc. (OTCQB: INTI) has provided an update on its clinical development plan for an itraconazole formulation to treat Basal Cell Carcinomas in Gorlin Syndrome patients. The company has submitted a Pre-Investigational New Drug application (PIND) to the FDA and received preliminary comments. INTI has engaged Avior Bio to develop a new proprietary formulation of itraconazole, which will be bridged to the formulation used in their completed clinical study via a pharmacokinetic study.
The completed clinical study showed promising results, with 399 out of 477 targeted tumors showing reduction, 275 tumors (57.7%) achieving a clinically meaningful reduction of 30% or greater, and 130 tumors (27.3%) resolving completely. Inhibitor aims to submit an Investigational New Drug Application (IND) to the FDA by the end of Q1 2025.
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