RedHill Biopharma Begins Phase 2 Trial for New Prostate Cancer Treatment

RedHill Initiates Phase 2 Study for Advanced Prostate Cancer

RedHill Biopharma Ltd., a company focused on developing treatments for gastrointestinal diseases and oncology, has just announced the start of a Phase 2 clinical trial assessing the effectiveness of a new treatment regimen for men suffering from metastatic castrate-resistant prostate cancer (mCRPC). The study involves 80 patients and aims to evaluate the combination of two drugs: opaganib and darolutamide. The trial, which is placebo-controlled and randomized, seeks to determine if opaganib can improve outcomes for patients who are resistant to existing therapies.

Study Objectives and Design

The Phase 2 trial will be supported financially by Bayer, a leader in health care products, along with the Ramsay Hospital Research Foundation. The research will be spearheaded by Professor Lisa Horvath from the Chris O'Brien Lifehouse and the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP).

Key to the study's design is the companion lipid biomarker test, dubbed PCPro, which will help identify mCRPC patients who have a poorer prognosis due to the ineffectiveness of standard treatments. Based on these findings, the trial will primarily focus on enhancing the 12-month radiographic progression-free survival (rPFS) rates.

Importance of the Trial

Prostate cancer is a significant global health issue, as it stands as the world’s second most prevalent cancer, with approximately 1.5 million new cases reported annually. Tragically, nearly 400,000 deaths are attributed to this disease every year. With the mCRPC subset having limited treatment options currently available, the findings of this study could represent a vital breakthrough in the management of advanced prostate cancer.

Mechanism of Action

Opaganib is a novel drug known for its ability to inhibit sphingosine kinase-2 (SPHK2), which is involved in multiple pathways impacting cancer cell survival, proliferation, and drug resistance. Professor Horvath has indicated that opaganib may enhance the efficacy of darolutamide, an androgen receptor signaling inhibitor, through its ability to block programmed cell death, thereby addressing a critical area of resistance in cancer treatment. This study is particularly anticipated as it marks a rare approach that integrates drug development with biomarker testing in a collaborative framework.

Dr. Mark Levitt, RedHill's Chief Scientific Officer, highlighted the limited treatment options available for mCRPC patients and pointed out that darolutamide is increasingly recognized as a key therapeutic agent in the prostate cancer landscape, which is valued at approximately $12 billion. If opaganib is proven effective, it could lead to substantial improvements in treatment outcomes for those with this challenging condition.

Future Directions

The trial will involve a systematic approach where potential participants identified as having the PCPro biomarker will undergo further screening. Those who qualify will be randomized into one of two treatment groups: one receiving darolutamide in combination with opaganib, and the other receiving darolutamide with a placebo. This methodology allows for a stringent assessment of the real impact of the new treatment regimen.

The overarching goal of the trial is not only to improve survival rates but also to challenge the prevailing treatment paradigms for mCRPC, providing hope to a patient population that faces a dire prognosis. In conjunction with this trial, opaganib's clinical potential is being explored in various other indications, including its response against different cancers and viral infections, illustrating RedHill’s commitment to pioneering healthcare solutions.

Conclusion

As RedHill Biopharma embarks on this critical study, the medical community remains hopeful that this innovative combination therapy could herald a new chapter in the fight against one of the most common cancer types affecting men globally. Continuous advancements in cancer research underscore the need for collaborative efforts that leverage both scientific inquiry and innovative approaches to improve patient care significantly.

About RedHill Biopharma
RedHill Biopharma Ltd. is a specialty biopharmaceutical firm committed to addressing serious health conditions through the development of novel therapies. More information about RedHill's varied treatment programs can be found on their official website.