AB Science SA announced that results from its Phase 3 AB09004 study on mild to moderate Alzheimer’s disease have been presented at the annual Alzheimer’s Association International Conference (AAIC) (July 26-30, 2021). The AAIC is the international meeting dedicated to the latest Alzheimer’s and dementia research. Last year’s virtual conference event attracted over 31,000 registered attendees. and scientific presentations (more than 3,000). This year the Alzheimer’s Association International Conference (AAIC) is taking place both in person (Denver, USA) and online (hybrid model of delivery). Professor Bruno Dubois, director of the Institute of Memory and Alzheimer’s Disease at the Pitié Salpêtrière Hospital in Paris and coordinating investigator of study AB09004, presented key results as part of the meeting’s session on human clinical trials. Study AB09004 was the first successful phase 3 randomized trial in mild-to-moderate Alzheimer’s disease of a drug targeting innate immune cells of the neuroimmune system. Masitinib at 4.5 mg/kg/day showed significant benefit over placebo according to the primary analysis, with an acceptable safety profile. Primary efficacy analysis (based on multiple endpoints, each tested at a significance level of 2.5%) was the least-squares mean change from baseline to week-24 in either the 11-item Alzheimer’s Disease Assessment Scale - cognitive subscale (ADAS-cog), or the 13-item Alzheimer’s Disease Cooperative Study Activities of Daily Living Inventory scale (ADCS-ADL). Results showed that masitinib can generate a significant treatment effect relative to placebo in the primary endpoint of change from baseline in ADAS-Cog, an instrument that measures the effect on cognition and memory. Specifically, masitinib 4.5 mg/kg/day (n=182) showed significant benefit relative to placebo (n=176), with a respective change in ADAS-cog from baseline of -1.46 (representing an overall improvement in cognition) versus +0.69 (representing increased cognitive deterioration); a corresponding ADAS-cog between-group difference of -2.15 (97.5%CI [-3.48, -0.81]), p=0.0003. It was also seen that masitinib generated a benefit in Alzheimer’s Disease Cooperative Study Activities of Daily Living (ADCS-ADL) score, an instrument that assesses self-care and activities of daily living. Specifically, masitinib 4.5 mg/kg/day showed a change in ADCS-ADL from baseline of +1.01 (representing an overall functional improvement) versus -0.81 for placebo (representing increased functional deterioration); a corresponding ADCS-ADL between-group difference of +1.82 (97.5%CI [(-0.15, 3.79]), p=0.038. The safety of masitinib as an adjunct to cholinesterase inhibitor and/or memantine was acceptable and consistent with its known tolerability profile. It is noteworthy that this result is in the context of a relative elderly population (average age of about 73 years) with comorbidities. The incidence of patients having at least one treatment-emergent adverse event (AE) after 24 weeks of treatment was 87% for masitinib 4.5 mg/kg/day versus 77.5% for the placebo-control group. This corresponds to an incidence rate ratio (masitinib/placebo) of 1.1. The incidence of severe AE for masitinib 4.5 mg/kg/day was 26.5% versus 19.3% in the placebo-control group, corresponding to an incidence rate ratio of 1.4.