Posted 30 Dec. 2022 at 10:58
The year 2022 is ending in the best possible way for AB Science. The French biotech announced last night that the Food & Drug Administration (FDA), the American health authority, had given the green light to the start of the phase III clinical study in the United States – i.e. the last step before a potential commercialization – aiming to test the molecule masitinib in the treatment of progressive forms of multiple sclerosis.
Masitinib, an orally administered tyrosine kinase inhibitor developed by the Parisian company, is AB Science’s most advanced experimental treatment. He is in phase III in amyotrophic lateral sclerosis, better known as Charcot’s disease, or Alzheimer’s disease. It is also tested on inflammatory diseases such as indolent systemic mastocytosis (also phase III) or in oncology (pancreatic cancer, metastatic prostate cancer, in phase II).
“The AB20009 study [visant à tester le masitinib contre les formes progressives de la SEP] is in the active recruitment phase [des patients volontaires]says AB Science in a press release. This is a phase III randomized double-blind study aimed at evaluating the safety and efficacy of masitinib administered at a dose of 4.5 mg/kg/day in patients with primary progressive multiple sclerosis ( PPMS) or non-active secondary progressive multiple sclerosis (nSPMS). »
+30% on the stock market over the week
The good news is linked this week for AB Science, whose shares are posting a weekly gain of 30%, including +15% today (-33% over the year 2022). Tuesday evening, the specialist in neurological diseases had made it known that masitinib had been granted orphan drug designation by Swissmedic in Switzerland, the authority for the authorization and monitoring of therapeutic products, for the treatment of ALS, from which the famous scientist Stephen Hawking suffered. It allows increased patent protection, extended for fifteen years in the Swiss case, exemption from registration fees, as well as a facilitated and accelerated authorization procedure.
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Orphan disease status is reserved, in Switzerland, for medicinal products targeting a rare, fatal or chronically disabling disease, the prevalence of which does not affect more than 5 people out of 10,000, or whose active substance has been recognized as an important medicinal product for rare diseases in another country with equivalent drug control.
AB Science recalls that masitinib has already received orphan drug designation for ALS from the FDA and the European Medicines Agency (EMA).
