INHIBITOR believes it can significantly reduce the risk and time to FDA marketing approvals for its patent-protected formulation of itraconazole in the United States because of the history of the safe use of itraconazole in humans for anti-fungal indications. SUBA-Itraconazole testing for the BCCNS indication was cleared by FDA in 2014 to move directly into a Phase 2b human trial in patients with basal cell carcinoma nevus syndrome thus surpassing each of the required pre-clinical animal studies for toxicity and Phase 1 human trials to establish safety. Under this precedent, we have applied for and received an Investigational New Drug (IND) clearance for a Phase 2b trial for the treatment of late-stage, castrate resistant prostate cancer and also intend to apply for an IND clearance for lung cancer testing in a Phase 2 clinical trial to study the use of SUBA-Itraconazole for late-stage disease.
INHIBITOR is advancing a growing pipeline of compounds for the treatment of cancer and has actively interfaced with FDA to achieve IND clearance at the end of 2019 authorizing a Phase 2b clinical study for its lead program, SUBA-Itraconazole Prostate. INHIBITOR also plans to advance SUBA-Itraconazole testing for lung cancer by requesting a pre-IND meeting with the FDA during Q4 2021.