India Pharma Outlook Team | Saturday, 05 July 2025
A substantial milestone in the therapeutic market of advanced prostate cancer, RedHill Biopharma Ltd. has launched the patient enrollment in a larger Phase 2 study focusing on metastatic castrate-resistant prostate cancer (mCRPC). The project indicates the interest of the industry in the development of a solution to the problem of resistance to androgen receptor pathway inhibition (ARPI), which is a major issue in late-stage treatment of prostate cancer.
This trial, funded by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP) and sponsored by both Bayer and Ramsay Hospital Research Foundation, tests the efficacy of the RedHill opaganib drug, in combination with another drug, darolutamide, developed by Bayer. The randomized, placebo-controlled study is headed by Professor Lisa Horvath and will involve 60 study participants sourced across the Australian and New Zealand sites.
The trial aims to determine if opaganib can help overcome ARPI resistance, potentially improving outcomes in patients with poor prognoses. A companion biomarker test will be used to identify such patients, adding a precision medicine angle to the research.
“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.”
The study’s primary endpoint is 12-month radiographic progression-free survival, with secondary and exploratory measures included. With the global prostate cancer market valued at $12 billion in 2023, and mCRPC representing a critical unmet need, this trial positions RedHill Biopharma at the forefront of innovation in urologic oncology.
