Israeli pharmaceutical company RedHill Biopharma has initiated a placebo-controlled Phase II trial to assess the combination of opaganib and darolutamide in treating metastatic castrate-resistant prostate cancer (mCRPC).
The study involves 80 male subjects and aims to determine if opaganib can enhance the effects of standard androgen receptor pathway inhibition (ARPI) treatments.
Go deeper with GlobalData
The randomised trial uses a companion lipid biomarker test, PCPro, to identify mCRPC patients with a poor prognosis who may benefit from the combination.
In the trial, 200 eligible subjects will be screened using a 5ml plasma sample for the PCPro test, with treatment due to begin within seven days of randomisation.
Improvement in 12-month radiographic progression-free survival is the trial’s primary endpoint, with various secondary and exploratory endpoints also under evaluation.
The study was designed and is being led by Prof Lisa Horvath, a prostate cancer researcher at the Chris O’Brien Lifehouse in Australia, as well as the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP).
It is being financially supported by German pharmaceutical company Bayer alongside the Ramsay Hospital Research Foundation.
RedHill chief scientific officer Dr Mark Levitt said: “Men with mCRPC have few treatment options available to them, and those positive for the PCPro marker of ARPI resistance seem to have a particularly poor prognosis.
“Darolutamide is establishing itself as a key therapy in the treatment of prostate cancer, a market worth approximately $12bn in 2023.
“If the addition of opaganib can reduce the resistance to darolutamide therapy, this could represent a significant breakthrough in improving the ability to manage advanced treatment-resistant mCRPC for improved outcomes.”
Opaganib is an investigational therapy with potential applications for several conditions, including cancer, obesity-related disorders, viral infections and diabetes.
RedHill Biopharma previously published positive outcomes from a Phase II trial of its antiviral RHB-107 (upamostat) in non-hospitalised Covid-19 patients.
