Acumen Pharmaceuticals announced positive topline results from a Phase 1 study of its Alzheimer’s drug, sabirnetug. The study compared subcutaneous (SC) and intravenous (IV) delivery methods in healthy volunteers, finding weekly SC injections were well-tolerated and achieved systemic exposure sufficient for further development. This is particularly relevant as the company’s lead candidate is currently being studied through IV infusions.
This development is a crucial step for Acumen and potentially for Alzheimer’s patients. A shift to subcutaneous administration could significantly improve patient convenience by eliminating the need for regular IV infusions, thereby potentially increasing treatment adherence and accessibility, which is especially critical for managing chronic conditions like Alzheimer’s. This could differentiate sabirnetug in a competitive Alzheimer’s treatment landscape.
The Phase 1 study involved 12 subjects receiving single IV doses of 2,800 mg and 16 subjects receiving four weekly SC doses of 1,200 mg. The most frequent adverse events were mild injection site reactions that resolved without intervention. Critically, the SC delivery achieved systemic drug levels comparable to IV, paving the way for future studies using this more patient-friendly administration route. Acumen’s ongoing Phase 2 ALTITUDE-AD study is currently evaluating the efficacy and safety of IV sabirnetug in early Alzheimer’s patients. The subcutaneous formulation utilizes Halozyme’s ENHANZE technology, which facilitates larger volume injections and faster absorption.
The positive Phase 1 results suggest a subcutaneous formulation of sabirnetug could become a viable and preferred option for Alzheimer’s patients. This could represent a significant advancement in treatment accessibility and patient compliance, potentially strengthening Acumen’s market position and accelerating broader access to this promising therapeutic candidate. Further clinical trials will be essential to confirm the efficacy and long-term safety of the subcutaneous formulation.
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.
