AB Science: U.S. Patent on Masitinib Granted Until 2042
AB Science announced on Wednesday that it has been granted a U.S. patent protecting masitinib until May 2042 for the treatment of hormone-resistant metastatic prostate cancer (mCRPC). This protection adds to the coverage already granted in Europe and similar applications in other major international markets.
A Patent Protecting a Key Molecule of the Parisian Biotech Until 2042
The U.S. Patent Office has issued a patent (US 12 648 944) relating to the methods of treating hormone-resistant metastatic prostate cancer with masitinib, AB Science's flagship molecule. The granted protection extends until May 2042. This new U.S. patent complements the coverage already in effect in Europe (EP4175639) and similar applications have also been filed in other major international markets.
Masitinib in Combination with Standard Chemotherapy
The patent specifically protects the use of masitinib in a sub-population of patients with mCRPC who have low metastatic involvement, measured by the alkaline phosphatase level at inclusion. Masitinib is administered in combination with docetaxel, the only chemotherapy drug registered for this indication. No drug in combination or as a replacement for docetaxel has improved progression-free survival or overall survival in the last 20 years. Masitinib is among the few molecules that have generated positive data on progression-free survival in combination with docetaxel in this population.
Clinical Data Supporting the Efficacy of the Positioning
The AB12003 study, a phase 3 double-blind placebo-controlled trial, demonstrated the significant benefit of masitinib at a dose of 6.0 mg/kg/day combined with docetaxel in patients with mCRPC and an alkaline phosphatase level of 250 IU/mL or less. The hazard ratio for progression-free survival is 0.79 (confidence interval 0.64-0.97, p = 0.0087), corresponding to a 21% risk reduction in progression compared to the control. The effect is more pronounced in patients with a lower alkaline phosphatase level at inclusion, reflecting less advanced metastatic disease, with a 47% risk reduction in progression for those with a level of 100 IU/mL or less (hazard ratio 0.53, p = 0.002). The tolerance profile was deemed acceptable, with no new safety signals detected.
