Acumen Pharmaceuticals has completed enrollment in its Phase 2 ALTITUDE-AD trial of sabirnetug (ACU193) for early-stage Alzheimer’s disease. The company enrolled 542 patients and expects topline results, including efficacy and safety data, in late 2026. Sabirnetug is a humanized monoclonal antibody selectively targeting soluble amyloid beta oligomers (AβOs), believed to be a key driver of Alzheimer’s.
This accelerated enrollment underscores the significant unmet need for effective Alzheimer’s treatments and the interest in sabirnetug’s novel mechanism of action. If successful, sabirnetug could represent a substantial advancement in Alzheimer’s treatment, offering a new approach to slowing or halting disease progression by targeting AβOs, a target not addressed by currently approved therapies. This could potentially lead to improved outcomes for patients and reshape the Alzheimer’s treatment landscape.
The ALTITUDE-AD trial is a randomized, double-blind, placebo-controlled study evaluating two doses of sabirnetug (35mg/kg and 50mg/kg) administered every four weeks. The primary endpoint is the change from baseline in the Integrated Alzheimer’s Disease Rating Scale (iADRS) at 18 months. Secondary endpoints include measures of cognitive function, activities of daily living, and various biomarkers. The Phase 1 INTERCEPT-AD trial demonstrated that sabirnetug was generally well-tolerated and effectively engaged its target.
The completion of enrollment marks a crucial step towards potentially bringing a new Alzheimer’s therapy to market. Positive results from the ALTITUDE-AD trial could pave the way for Phase 3 studies and eventual regulatory approval, offering hope for a new and potentially more effective treatment option for individuals with early-stage Alzheimer’s disease. This development may also spur further research into AβOs as a therapeutic target and drive innovation in the field of Alzheimer’s drug development.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
