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.
For more information about Inhibitor and our mission please visit us on our website (www.inhibitortx.com) and for any further or specific questions you may have please visit our contact us page, submit your details/query, and a representative will be happy to respond.
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