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Company Overview

 

INHIBITOR Therapeutics, Inc. is a publicly traded pharmaceutical company (OTCQB:INTI) focused on developing and commercializing innovative therapies for patients with cancer and non-cancerous proliferation disorders.

SUBATM-Itraconazole, the company’s lead product candidate, is a patented, oral formulation of the currently FDA approved and marketed, well-understood, anti-fungal drug, itraconazole, which, when studied to treat patients with cancer, has demonstrated activity against multiple tumor types. INHIBITOR is developing SUBA-Itraconazole for late-stage, metastatic castrate-resistant prostate cancer (mCRPC) and late-stage non-squamous non-small cell lung cancer (NSCLC). INHIBITOR is the exclusive U.S. licensee for SUBA-Itraconazole for the treatment of certain cancers and non-cancerous proliferation disorders.

Inhibitor-Therapeutics

INHIBITOR’s lead programs are clinically de-risked due to itraconazole’s prior FDA approval (505(b)(2) pathway), with proven bioavailability, safety and anti-tumor efficacy previously demonstrated in an INHIBITOR clinical trial testing SUBA-Itraconazole in 38 patients with Basal Cell Carcinoma Nevus Syndrome (BCCNS). Solid clinical execution was demonstrated with the completion of a Phase 2b trial in BCCNS, confirming a low toxicity safety profile when compared to published data for other oncology drugs that inhibit the same pathway as a treatment for basal cell carcinoma (BCC) lesions.

 

Based upon guidance during a Pre-IND (Investigational New Drug) meeting with FDA in the second quarter of 2019 regarding its prostate cancer program, INHIBITOR has filed a request for an EoP2 (End of Phase 2) Meeting with FDA expected to occur in the fourth quarter of 2019 to reach agreement with FDA on the protocol and statistical analysis plan for a Phase 2b clinical trial. The trial will study the safety and efficacy of SUBA-Itraconazole dosing in conjunction with chemotherapy in men with mCRPC. Based upon further guidance at that meeting with FDA, INHIBITOR will then file an IND application for its prostate cancer program. Upon FDA clearance, INHIBITOR will be authorized to launch its Phase 2b testing in late-state prostate cancer.

 

In addition to the SUBA-Itraconazole clinical development programs for prostate and lung cancer, INHIBITOR plans to expand its pipeline by opportunistically acquiring/licensing additional compounds for the treatment of cancer, as well seeking innovative therapeutics addressing unmet needs and orphan indications. One such program involves pre-clinical testing of itraconazole analogues, discovered by the University of Connecticut, and for which the company has an exclusive option agreement for world-wide rights, as a potential treatment for patients with poorly operable BCC tumors as an adjunct therapy to surgery in order to minimize surgical disfigurement, particularly for lesions that occur on the face and neck.