RedHill Biopharma Ltd (NASDAQ: RDHL), an Israeli specialty biopharmaceutical company, announced on Tuesday the initiation of patient recruitment into the Phase 2 study evaluating the efficacy of opaganib3 in combination with darolutamide4 in men with metastatic castrate-resistant prostate cancer (mCRPC), sponsored by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group Ltd (ANZUP) in Australia, and supported by Bayer (ETR:BAYN) and Ramsay Hospital Research Foundation.

The study will recruit people across at least 10 sites across Australia and New Zealand.

Led by Professor Lisa Horvath, from Sydney's Chris O'Brien Lifehouse, and ANZUP, the innovative 60-participant placebo-controlled randomised study is designed to test the potentially enhancing effect of opaganib in overcoming resistance to standard of care androgen receptor pathway inhibition (ARPI) treatment.

The company says that the unique study will utilise a companion lipid biomarker test (PCPro5) to select mCRPC patients who have poor prognosis to standard of care treatment, and who may benefit from an opaganib + darolutamide combination approach to treatment. Primary endpoint is improved 12-month radiographic progression-free survival (rPFS). Several secondary and exploratory endpoints will also be evaluated.

The study is a double-blind, placebo-controlled randomised Phase 2 trial, adding opaganib to darolutamide in people with mCRPC and poor prognosis (as defined by plasma lipid signature, PCPro).