On 10 October, AB Science, a late-clinical-stage French company with the goal of developing innovative drugs for high unmet medical needs, announced that the first authorisations have been received to initiate a phase III study evaluating masitinib in people with mild to moderate Alzheimer's disease (AD). The Phase III trial AB21004 is a randomised and double-blind study aiming to evaluate the safety and efficacy of masitinib in people with mild to moderate AD, as an add-on therapy to standard of care, cholinesterase inhibitors and/or memantine. 600 participants with confirmed clinical diagnosis of mild and moderate AD will receive either placebo or masitinib orally twice daily. Participants receiving masitinib (3.0 mg/kg/day) will receive a dose escalation of 4.5 mg/kg/day after 4 weeks of treatment. Dose up-titration is subjected to a safety control. Placebo and masitinib will be administered as an add-on to cholinesterase inhibitor (donepezil, rivastigmine or galantamine) and/or memantine standard of care (SOC). The primary endpoint of the study will be to evaluate the effect of masitinib on absolute change from baseline in ADCS-ADL score and in ADAS-Cog-11. The Phase III trial will recruit participants in several EU countries. Authorisations have already been received from the French Medicine Agency (ANSM) together with AEMPS (Spain agency) and EOF (Greece agency). https://www.ab-science.com/ab-science-receives-first-agencies-authoriza…
