On 16 December, the pharmaceutical company AB Science announced that its Phase II/III clinical trial evaluating Masitinib in Alzheimer’s disease (AD) met its primary endpoint. Masitinib is an oral drug classed as a tyrosine kinase inhibitor that targets important cells for immunity.
The 24-week trial was a multicenter, double-blind, randomised and placebo-controlled study evaluating the efficacy and safety of masitinib as an add-on therapy to cholinesterase inhibitors and/or memantine. 718 European participants with mild and moderate AD who have been treated for a minimum of 6 months with a stable dose of cholinesterase inhibitor (donepezil, rivastigmine or galantamine) and/or memantine received placebo or one of two doses of masitinib. The co-primary outcome measures were the Alzheimer's Disease Cooperative Study Activities of Daily Living score (ADCS-ADL) and Alzheimer's Disease Assessment Scale-Cognitive Subscale score (ADAS-Cog) after 24 weeks of treatment.
The study reported that masitinib (4.5 mg/kg/day) had a significant treatment effect compared to the control on both cognition and daily activity measured by the two primary endpoints. The company added that the safety of masitinib was acceptable and consistent with the known tolerability profile for masitinib.
The company plans to present study results at an upcoming conference.
