PRESS RELEASE
FROM SCIENCE GETS FIRST AGENCIES AUTHORIZATIONS TO INITIATE CONFIRMED PHASE 3 CLINICAL STUDY WITH MASITINIB IN THE TREATMENT OF ALZHEIMER ILLNESS
Paris, October 10thth2022, 6 p.m CET
AB Science S.A (Euronext – FR0010557264 – AB) announced today that it has received initial approvals to start its confirmatory Phase 3 study (AB21004) from the French Medicine Agency (ANSM) in conjunction with AEMPS evaluating masitinib in patients with mild to moderate Alzheimer’s disease -Disease (AD) were granted (Spain Agency) and EOF (Greece Agency).
Study AB21004 is a phase 3, randomized, double-blind study evaluating the safety and efficacy of masitinib in patients with mild to moderate Alzheimer’s disease as add-on therapy to standard of care, cholinesterase inhibitors, and/or memantine. The study will enroll 600 patients with a confirmed clinical diagnosis of mild and moderate Alzheimer’s disease, with an Activities of Daily Living (ADCS) ADL score of less than 73 and a Mini Mental State Examination (MMSE) score between 14 and 25 match. included.
The objective of study AB21004 is to confirm the treatment effect of masitinib 4.5 mg/kg/day as an adjunct to a cholinesterase inhibitor and/or memantine in patients with mild to moderate Alzheimer’s disease. The primary endpoint of the study will be to assess the effect of masitinib on absolute change from baseline in ADCS-ADL score and ADAS-Cog-11.
The positioning of masitinib differs from other Alzheimer’s drugs such as lecanemab, aduhelm, donanemab, and crenenzumab, which target the earliest stages of the AD continuum, including very mild dementia, prodromal or asymptomatic Alzheimer’s disease, MMSE>22 and up to 30 , while patients with MMSE 27-30 have normal cognitive functions.
Masitinib’s mechanism of action also differs from other drugs being developed for Alzheimer’s disease and may be complementary in that masitinib targets microglia and mast cells for disease-modifying effects…
