AB Science receives Japanese patent protection for the use of masitinib in progressive forms of multiple sclerosis (MS) until 2041

Core Viewpoint - AB Science has received a Japanese patent for the use of masitinib in treating progressive forms of multiple sclerosis (MS), providing intellectual property protection until February 2041, marking Japan as the first country to grant this patent [1][2]. Group 1: Patent and Market Position - The patent granted in Japan (JP 7788154) is the first for masitinib in progressive MS, following a similar successful patent strategy for amyotrophic lateral sclerosis (ALS) [2]. - AB Science is optimistic about obtaining global patent protection for masitinib in progressive MS, similar to its ALS patent [2]. - The company is pursuing a secondary medical use patent strategy for various indications, including progressive MS, Alzheimer's Disease, and prostate cancer, with protection extending into the 2040s [3]. Group 2: Clinical Studies and Efficacy - Masitinib has shown a unique and competitive positioning in treating both primary progressive multiple sclerosis (PPMS) and non-active secondary progressive multiple sclerosis (nSPMS) [3]. - The development of masitinib is supported by positive results from phase 2b/3 study (AB07002) and the confirmatory phase 3 MAXIMS study (AB20009), with the former showing a statistically significant reduction in disability progression [3][4]. - In study AB07002, masitinib 4.5 mg/kg/day reduced the risk of first disability progression by 42% and improved manual dexterity, with a significant reduction in the risk of reaching an EDSS score of 7.0 [3][4]. Group 3: Safety Profile - The safety profile of masitinib is well characterized, based on data from over 4,300 patients, with no increased risk of infection observed [5][6]. - Masitinib is the first and only drug in phase 3 trials designed to target both mast cells and microglia, which is an effective strategy for treating progressive forms of MS [8]. - Unlike BTK inhibitors, masitinib does not target B-cells, which are associated with increased infection risk, making it a safer option for patients with progressive MS [6][8]. Group 4: Medical Need and Market Context - There is a significant medical need for treatments targeting progressive forms of MS, which affect over 100,000 people in France alone, with no definitive treatment currently available [10]. - Progressive forms of MS account for approximately 50% of all MS cases, highlighting the unmet medical need in this patient population [13]. - Recent failures of BTK inhibitors in clinical trials for MS further emphasize the demand for effective therapies like masitinib [14].