RedHill Biopharma (RDHL) announced the initiation of a Phase 2 clinical study to evaluate the efficacy of its opaganib candidate in combination with darolutamide in men with metastatic castrate-resistant prostate cancer. Financially supported by Bayer and the Ramsay Hospital Research Foundation, the 80-patient placebo-controlled randomized study is designed to test the potentially enhancing effect of opaganib in overcoming resistance to standard of care androgen receptor pathway inhibition treatment. The study’s primary endpoint will be improved 12-month radiographic progression-free survival. Several secondary and exploratory endpoints will also be evaluated.
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