RedHill Biopharma Ltd. has announced the start of patient recruitment for an expanded Phase 2 clinical trial evaluating a combination of opaganib and darolutamide in men with metastatic castrate-resistant prostate cancer (mCRPC). The study is sponsored by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP) and supported by Bayer and the Ramsay Hospital Research Foundation.

Led by Professor Lisa Horvath, the randomized, placebo-controlled trial will recruit 60 participants across multiple sites in Australia and New Zealand. The aim is to assess whether opaganib can help overcome resistance to standard androgen receptor pathway inhibition (ARPI) therapy.

The trial will also use a companion biomarker test to identify patients with poor prognosis under standard treatment, potentially improving outcomes with the opaganib-darolutamide combination. The primary goal is to evaluate 12-month radiographic progression-free survival, with additional secondary and exploratory endpoints.

Opaganib has shown potential in enhancing ARPI treatment by blocking multiple enzymes involved in cancer cell survival. This mechanism could be key in treating advanced prostate cancer that no longer responds to standard therapies.

Prostate cancer remains one of the most common cancers worldwide, with a high disease burden and an estimated global market value of $12 billion in 2023.