AB Science SA announced that the Phase 2B/3 study (AB09004 - NCT01872598) evaluating oral masitinib in patients with mild and moderate Alzheimer’s disease met its predefined primary endpoint. Study AB09004 was an international, randomized, placebo-controlled, phase 2B/3 study evaluating different doses of masitinib as a treatment of patients with confirmed mild to moderate Alzheimer’s disease. This study compared the efficacy and safety of masitinib relative to placebo after 24 weeks of treatment when administered as an add-on therapy to cholinesterase inhibitor (donepezil, rivastigmine or galantamine) and/or memantine. Two doses of masitinib were tested, masitinib 4.5 mg/kg/day and a titrated dose of masitinib from 4.5 to 6.0 mg/kg/day, with each dose having an independent control arm. The study demonstrated that masitinib 4.5 mg/kg/day (n=182) generated a significant treatment effect compared with the control arm (n=176) on the primary endpoint of change from baseline in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog), an instrument that measures the effect on cognition and memory (p=0.0003). The study also demonstrated that masitinib 4.5 mg/kg/day generated a significant change from baseline in Alzheimer’s Disease Cooperative Study Activities of Daily Living (ADCS-ADL) score, an instrument that assesses self-care and activities of daily living (p= 0.0381). There were significantly fewer patients reaching severe dementia stage (MMSE<10) with masitinib 4.5 mg/kg/day compared with placebo after 24 weeks of treatment (p-value= 0.0446). The safety of masitinib 4.5 mg/kg/day was acceptable and consistent with the known tolerability profile for masitinib: 79.5% of patients had at least one adverse event in the masitinib arm versus 74.6% in the control arm; 5.9% of patients had at least one serious adverse event (non-fatal) in the masitinib arm versus 2.9% in the control arm; 18.9% of patients had at least one severe adverse event in the masitinib arm versus 16.8% in the control arm. A new patent was filed based on results from study AB09004. Said patent, if granted, would permit AB Science to retain exclusive rights on the use of masitinib in Alzheimer’s disease until 2041.