The PREDICT trial is designed to evaluate the efficacy and safety of SUBA-Itraconazole capsules, in combination with docetaxel and prednisone in patients with mCRPC
Inhibitor Therapeutics receives FDA IND approval for PREDICT trial. (Credit: valelopardo/Pixabay.)
Inhibitor Therapeutics has received the US Food and Drug Administration (FDA) approval to start an Investigational New Drug (IND) clinical trial of SUBA-Itraconazole capsules plus docetaxel and prednisone for a type of metastatic castrate-resistant prostate cancer (mCRPC).
The biopharmaceutical firm said that the IND study, dubbed prostate response evaluating Docetaxel Itraconazole combination therapy (PREDICT), is a multi-centre, randomized, double-blind, placebo-controlled, Phase 2b clinical trial.
Inhibitor president and CEO Nicholas Virca said: “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.”
Itraconazole is an antifungal medication used for prostate cancer
The PREDICT trial is designed to evaluate the efficacy and safety of SUBA-Itraconazole capsules, in combination with docetaxel and prednisone in patients with mCRPC, across 35 sites in six countries in North America, Western Europe and Eastern Europe.
Itraconazole is an antifungal medication that prevents the ciliary accumulation of SMO, a component of Hedgehog signalling pathway, in human cells.
The company said that Itraconazole has been evaluated in a Phase 2 trial as a treatment for mCRPC in 2013, which showed promising PSA reductions along with rPFS.
In addition, the drug has demonstrated superior bioavailability in other clinical studies, compared to generic itraconazole, an FDA approved treatment of certain fungal infections.
Virca added: “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.
“I would once again like to acknowledge the efforts of our regulatory and clinical team members during 2019 to achieve this level of progress for our SUBA-Itraconazole Prostate program. We look forward to further updating our shareholders as we take subsequent steps to move this program into the clinic.”