Inhibitor Therapeutics Inc. Receives Investigational New Drug Clearance from the U.S. Food and Drug Administration
January 22, 2020 at 08:05 am
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Inhibitor Therapeutics Inc. announced that the company has received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) to initiate an IND-opening clinical study as a two-part, multi-center, randomized, double-blind, placebo-controlled, Phase 2b clinical trial that will 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 Phase 2b trial is named PREDICT (Prostate Response Evaluating Docetaxel Itraconazole Combination Therapy). The PREDICT trial is expected to be carried out across approximately 35 sites in six countries in North America, Western Europe and Eastern Europe. SUBA-Itraconazole will be tested to determine its potential to address an unmet need in these patients, who exhibit disease progression or who have discontinued the other therapies due to toxicity or other reasons.
Inhibitor Therapeutics, Inc. is a pharmaceutical development company. The Company is focused on developing and commercializing therapeutics based on already approved active pharmaceuticals that have patent-protected methods of use and/or methods of delivery for patients with certain cancers and certain non-cancerous proliferation disorders. Its primary focus is on the development of therapies initially for basal cell carcinoma (BCC), prostate and lung cancers in the United States utilizing itraconazole, a drug approved by the United States Food and Drug Administration (FDA) to treat fungal infections. The Company has developed intellectual property and know-how related to the treatment of cancer patients using itraconazole. The Company's intellectual property in the form of issued United States patents includes treatment and prognostic monitoring of proliferation disorders using hedgehog pathway inhibitors, and treatment of lung cancer using hedgehog pathway inhibitors.
INHIBITOR THERAPEUTICS, INC. 
