On 19 March, Acumen Pharmaceuticals, a clinical-stage biopharmaceutical company developing therapeutics for the treatment of Alzheimer’s disease (AD), announced topline results from its Phase 1 study of sabirnetug. This study, which was conducted in healthy volunteers, enrolled 12 participants who received single intravenous doses of sabirnetug (2.800mg) and 16 participants who received four weekly subcutaneous doses of sabirnetug (1.200mg). Findings showed that weekly subcutaneous administration of sabirnetug was well-tolerated with sufficient systemic exposure supporting further clinical development. The most frequently reported adverse events included injection site reactions, all of which were mild in severity and resolved. No other safety signals were identified. Sabirnetug is currently being evaluated in a Phase 2 study in people with early AD.
The ALTITUDE-AD study is a multi-center, randomised, double-blind and placebo-controlled clinical trial designed to evaluate the efficacy and safety of sabirnetug, when administered intravenously once every four weeks in slowing cognitive and functional decline as compared to placebo in participants with early AD. The study will enroll approximately 540 participants with early AD in the United States, Canada, UK and the European Union.