INHIBITOR Therapeutics announced the company has received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) to initiate an IND-opening phase 2b trial to evaluate the efficacy and safety of SUBA-Itraconazole capsules dosed in combination with docetaxel and prednisone in patients with metastatic castrate resistant prostate cancer (mCRPC).
The two-part Phase 2b multi-center, randomized, double-blind, placebo-controlled trial, named PREDICT (Prostate Response Evaluating Docetaxel Itraconazole Combination Therapy), is expected to be carried out across approximately 35 sites in six countries in North America, Western Europe and Eastern Europe.
Nicholas J. Virca, INHIBITOR’s President and CEO, commented “Following a face-to-face End-of-Phase-2 meeting with FDA last October and our submission of an IND application thereafter, I am pleased to announce that we have received IND clearance for our PREDICT trial. FDA confirmed that we can follow the 505(b)(2) regulatory pathway and, assuming positive results demonstrating an improvement in radiographic progression-free survival (rPFS) as our primary endpoint, also indicated that the general design and planned analysis of our study would adequately address the objectives necessary to support an eventual New Drug Application (NDA) submission for this indication. FDA also indicated that the final analysis of the key secondary endpoint of overall survival (OS) can occur following submission of the NDA for approval in the United States.”
About SUBA-Itraconazole capsules
SUBA-Itraconazole (which stands for “super bioavailability”) is a patented formulation of itraconazole, which is designed to improve the bioavailability of orally administered drugs that are poorly soluble. SUBA-Itraconazole has improved absorption and significantly reduced variability compared to generic Itraconazole, providing patients and prescribers with reduced intra- and inter-patient variability, enabling a more predictable clinical dose response and a reduction in the active drug quantity required to deliver therapeutic levels into the bloodstream.
Itraconazole is an FDA-approved prescription medication currently used to treat serious fungal or yeast infections. In addition to its anti-infective properties, itraconazole has also been shown to suppress growth of brain tumors in animal models and has demonstrated anti-cancer effects in basal cell carcinoma, lung and prostate cancers in human clinical trials. Itraconazole acts as an antagonist (blocker) of SMO (SMOOTHENED), a protein receptor of the Hedgehog pathway, in a manner distinct from its anti-fungal activity.Source: INHIBITOR Therapeutics