Recruitment initiated into the Phase 2 opaganib plus darolutamide study in patients with advanced prostate cancer, sponsored by ANZUP, and supported by Bayer and Ramsay Hospital Research Foundation

RedHill Biopharma , a specialty biopharmaceutical company, announced the initiation of patient recruitment into the Phase 2 study evaluating the efficacy of opaganib3 in combination with darolutamide4 in men with metastatic castrate-resistant prostate cancer (mCRPC), sponsored by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group Ltd. (ANZUP) in Australia, and supported by Bayer (ETR: BAYN) and Ramsay Hospital Research Foundation. The Company also announced the study will recruit people across at least 10 sites across Australia and New Zealand.

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Led by Professor Lisa Horvath, from Sydney’s Chris O’Brien Lifehouse, and ANZUP, the innovative 60-participant 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 (ARPI) treatment.

The unique study will utilize a companion lipid biomarker test (PCPro5) to select mCRPC patients who have poor prognosis to standard of care treatment, and who may benefit from an opaganib + darolutamide combination approach to treatment. The study’s primary endpoint is improved 12-month radiographic progression-free survival (rPFS). Several secondary and exploratory endpoints will also be evaluated.

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Cancer cells can block apoptosis (programmed cell death), an important cell-level process designed to help the body get rid of unneeded or abnormal/unhealthy cells, which are critical in fighting the spread of cancer. Prior research shows that opaganib enhances androgen receptor signaling inhibitor efficacy in vitro6, through simultaneous inhibition of three sphingolipid-metabolizing enzymes in human cells (SPHK2, DES1 and GCS), and may potentially provide the key to overcoming darolutamide resistance in men with mCRPC.

Prostate cancer is the second most diagnosed cancer in the world with around 1.5 million new cases per year, causing almost 400,000 deaths every year, while millions more people are living with prostate cancer resulting in a significant burden of disease.7 The global prostate cancer market was worth approximately $12 billion in 2023.8

About the Study

The study is a double-blind, placebo-controlled randomized Phase 2 trial, adding opaganib to darolutamide in people with mCRPC and poor prognosis (as defined by plasma lipid signature, PCPro). The target population of the study is people with mCRPC who have had no treatment with newer, potent AR signaling inhibitors including darolutamide, enzalutamide, apalutamide, or abiraterone. 200 people with prostate cancer who are identified as potentially eligible will have a 5-ml plasma sample taken for PCPro testing. Those who are PCPro-positive (estimated 40% of patients) and agree to enter the study will be randomized on a 1:1 ratio to either the darolutamide 600mg bid + placebo (n=30) arm or the darolutamide 600 mg bid + opaganib 500 mg bid (n=30) arm.

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Source – PR Newswire