A phase 2 clinical trial will start soon to evaluate the efficacy of combining opaganib (ABC294640) with darolutamide (Nubeqa) in treating patients with metastatic castration-resistant prostate cancer (mCRPC).

The study aims to enroll 80 participants and utilizes the PCPro lipid biomarker test to identify individuals who may benefit from this combination therapy. Initially, 200 potential participants will undergo PCPro testing using a 5-mL plasma sample, with an estimated 40% expected to test positive.

These PCPro-positive patients will be randomly assigned to receive either 600 mg of darolutamide twice daily plus a placebo or 600 mg of darolutamide twice daily combined with 500 mg of opaganib twice daily.

Opaganib is a sphingosine kinase-2 (SPHK2) inhibitor that targets specific pathways in cancer cells, potentially overcoming resistance to androgen receptor pathway inhibitors (ARPIs) in mCRPC. The primary endpoint of the trial is 12-month radiographic progression-free survival. Notably, patients who have previously been treated with potent ARPIs are excluded from participation.

This trial represents a significant step in exploring novel combination therapies for mCRPC, aiming to improve outcomes for patients with this challenging condition.

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