Inhibitor Therapeutics, Inc. Provides Update on its Clinical Development Plan
TAMPA, Fla., Aug. 22, 2024 (GLOBE NEWSWIRE) -- Inhibitor Therapeutics, Inc. ("Inhibitor") (OTCQB: INTI) today provided an update on development efforts for its itraconazole formulation for the treatment of Basal Cell Carcinomas in patients with Basal Cell Carcinoma Nevus Syndrome, otherwise known as Gorlin Syndrome. Inhibitor has allied with The Gorlin Syndrome Alliance and sought supportive guidance from the accomplished and highly-experienced members of its Scientific Advisory Board in efforts to pursue an expeditious path to acceptance by the U.S. Food and Drug Administration (FDA).
Inhibitor has submitted a Pre-Investigational New Drug application (PIND) which has been reviewed by the FDA’s Division of Dermatology and Dentistry and will have input from the Division of Oncology 3 where necessary. INTI has received preliminary comments from the FDA with guidance in preparation for an Investigation New Drug Application (IND)
Inhibitor has engaged Avior Bio for the development of a new proprietary/patentable formulation of itraconazole that will be bridged to the formulation used within Inhibitor’s completed clinical study and to the generic formulation of itraconazole via a pharmacokinetic (PK) study. Itraconazole has a well understood safety profile and, based upon the data developed in the completed clinical study, demonstrated clinically meaningful efficacy in the treatment of Basal Cell Carcinomas in patients with Gorlin Syndrome.
Of the 477 targeted tumors studied throughout the clinical study, it was reported that 399 had a reduction of any size, 64 had no change and 14 increased in size. A clinically meaningful reduction of size of 30% or greater was found in 275 (57.7%) of the 477 tumors; 130 (27.3%) of the targeted tumors resolved completely.
Inhibitor’s plan for continued development of its itraconazole therapeutic include i) completing the new proprietary formulation inclusive of patent creation; ii) conducting/compiling results of the bridging PK study; and iii) preparing and submitting its IND. Inhibitor anticipates that it will be prepared to submit this IND to the FDA for their review and guidance by the end of Q1 2025.
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Forward-Looking Statements
This press release contains projections and other forward-looking statements regarding future events and our future financial performance. All statements other than present and historical facts and conditions contained in this release, including any statements regarding future results of operations and financial positions, business strategy and plans, expectations for future product sales, our ability to convert our pipeline to revenue and our objectives for future operations, are forward-looking statements (within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended). These statements are only predictions and reflect our current beliefs and expectations with respect to future events and are based on assumptions and subject to risk and uncertainties and subject to change at any time. We undertake no obligation to update the information made in this release in the event facts or circumstances subsequently change after the date of this press release. We operate in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, you should not rely on or place undue reliance on these forward-looking statements. Actual events or results may differ materially from those contained in the projections or forward-looking statements.
Simon Bettink sbettink@inhibitortx.com
Released August 22, 2024