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 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 intend to apply for additional Investigational New Drug (IND) clearances for the treatment of prostate and lung cancers with individualized Phase 2 clinical trial protocols for each of these target cancer indications.
INHIBITOR is advancing a growing pipeline of compounds for the treatment of cancer and is actively interfacing with FDA ahead of a planned IND application and clearance before year end 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 2020.