(Boursier.com) — AB Science announced that its Phase III clinical study (AB21004) in mild to moderate Alzheimer’s disease has been approved by the US Food and Drug Administration (FDA). This decision follows similar authorizations received from several European countries, including the French Medicines Agency (ANSM).
The AB21004 study is a phase 3 randomized double-blind study aimed at evaluating the safety and efficacy of masitinib in patients with mild or moderate Alzheimer’s disease, in combination with reference treatments, namely inhibitors cholinesterase and/or memantine. The study should recruit 600 patients whose clinical diagnosis of mild or moderate Alzheimer’s disease has been confirmed, which corresponds to an MMSE (Mini Mental State Examination) score between 14 and 25, inclusive.
The objective of this study is to confirm the results of the first phase 2B/3 study which showed that masitinib administered at a dose of 4.5 mg/kg/day significantly slowed cognitive deterioration compared to placebo and reduced also the loss of functional ability in activities of daily living in the target population of patients with Alzheimer’s disease. The main endpoint of the study will be to assess the effect of masitinib on the change in the ADCS-ADL score and the ADAS-Cog-11 score, compared to inclusion.
AB Science recalls that the positioning of masitinib is different from that of other drugs developed in Alzheimer’s disease, such as lecanemab, aduhelm, donanemab and crenenzumab, which target the early stages of Alzheimer’s disease, including very mild dementia, prodromal or asymptomatic Alzheimer’s disease.
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