AB Science has received authorization from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to begin a confirmatory Phase 3 clinical trial of masitinib in combination with docetaxel for the treatment of metastatic castrate-resistant prostate cancer (mCRPC). This marks a major step forward for masitinib, with the trial using a biomarker to identify patients with less advanced metastatic disease. 

Masitinib is targeted at patients who are no longer responding to hormone-sensitive prostate cancer treatments and are eligible for chemotherapy with docetaxel. While docetaxel has been a standard therapy for nearly two decades, no combination treatment with it has been approved in this setting. Masitinib may represent the first potential new option for these patients. 

A previous Phase 3 trial (AB12003) showed that masitinib combined with docetaxel significantly delayed disease progression in mCRPC patients with low levels of the biomarker ALP (alkaline phosphatase). 

Importantly, the combination treatment was well tolerated, with no unexpected safety concerns. This positive outcome makes masitinib one of the few targeted therapies to show real benefit in this hard-to-treat population.

AB Science has secured a patent for masitinib in this indication, providing market exclusivity through 2042 in Europe, with filings underway in other major global regions, including the United States.