AB Science Granted Japanese Patent for Masitinib in Progressive Multiple Sclerosis
AB Science has announced that the Japanese Patent Office has issued a patent protecting the use of masitinib in the treatment of progressive forms of multiple sclerosis until February 2041. This marks the first country to grant such protection for this indication, according to the company's statement.
Patent Details and Global Protection Strategy
According to the pharmaceutical laboratory, the Japanese patent number JP 7788154 covers the methods of treating progressive multiple sclerosis with masitinib, its flagship molecule. AB Science reports that it followed the same methodology used to protect masitinib in amyotrophic lateral sclerosis, a patent that has been granted worldwide. The company is optimistic about obtaining similar protection globally for progressive multiple sclerosis. The firm also continues to pursue this secondary medical use patent strategy for several other indications, including amyotrophic lateral sclerosis until 2037, Alzheimer's disease until 2041, sickle cell disease until 2040, prostate cancer until 2042, and severe mastocytosis until 2036.
Clinical Development of Masitinib in Progressive Multiple Sclerosis
The development of masitinib in progressive forms of multiple sclerosis, including the PPMS and nSPMS subvariants, is based on the results of two clinical studies, the statement specifies. The phase 2b/3 study AB07002, which enrolled 656 patients, met its primary endpoint with a statistically significant reduction in the cumulative variation of the EDSS score at 4.5 mg/kg/day (p=0.0256), the company reports. According to AB Science, masitinib reduced the risk of first disability progression by 42% and improved manual dexterity as measured by the 9-hole peg test (p=0.0388). The company also emphasizes that the risk of reaching a score of 7.0 on the EDSS scale, corresponding to a level of disability requiring a wheelchair, was significantly reduced (p=0.0093). A confirmatory phase 3 study called MAXIMS (AB20009) is underway to validate these results.
Distinctive Profile of Masitinib
AB Science highlights the profile of masitinib, described as the first oral tyrosine kinase inhibitor in its class specifically targeting mast cells and microglia. According to the company, this approach differs from BTK inhibitors, another class of tyrosine kinase inhibitors developed for multiple sclerosis, which target B lymphocytes. The tolerance profile of masitinib is based on a database of more than 4,300 patients, with nearly 2,000 receiving the treatment for more than six months and 1,200 for over a year, the statement details. The laboratory emphasizes that the medical needs in progressive multiple sclerosis remain high, especially following the mixed results of BTK inhibitors, including Sanofi's tolebrutinib, which received a complete response letter from the FDA due to tolerance concerns.
