RedHill Announces Initiation of Phase 2 Study of Opaganib and Darolutamide in Advanced Prostate Cancer

Core Insights - The Phase 2 study aims to evaluate the efficacy of opaganib in combination with darolutamide for men with metastatic castrate-resistant prostate cancer (mCRPC) [1][2] - The study is financially supported by Bayer and the Ramsay Hospital Research Foundation, led by Professor Lisa Horvath [1][2] - Prostate cancer is the second most diagnosed cancer globally, with approximately 1.5 million new cases and nearly 400,000 deaths annually [1][5] Study Design - The study is a double-blind, placebo-controlled trial involving 80 patients, focusing on those with poor prognosis as defined by the PCPro lipid biomarker test [1][4] - The primary endpoint is improved 12-month radiographic progression-free survival (rPFS), with several secondary and exploratory endpoints also evaluated [2][4] Market Context - The prostate cancer market is valued at approximately $12 billion in 2023, highlighting the potential commercial significance of successful treatment options [3][5] - Men with mCRPC have limited treatment options, making the development of new therapies critical for improving patient outcomes [3][5] Mechanism of Action - Opaganib is a sphingosine kinase-2 (SPHK2) inhibitor that may enhance the efficacy of androgen receptor signaling inhibitors like darolutamide [3][7] - The drug targets multiple pathways, potentially overcoming resistance to standard treatments [3][8] Clinical Implications - The study's findings could represent a significant breakthrough in managing advanced treatment-resistant mCRPC, improving outcomes for patients with poor prognosis [3][4] - The combination therapy may provide a new avenue for treatment in a patient population that currently faces high mortality rates [3][5]