Acumen Pharmaceuticals has expanded its collaboration with Lonza to include drug product (DP) manufacturing for sabirnetug (ACU193), an investigational therapy for early Alzheimer's disease (AD). This agreement builds upon their existing partnership, where Lonza manufactures the drug substance (DS) for sabirnetug used in ongoing clinical studies.
Sabirnetug: Targeting Toxic Amyloid Beta Oligomers
Sabirnetug is a humanized monoclonal antibody designed to selectively target soluble amyloid beta oligomers (AβOs), a toxic form of Aβ implicated in the early stages of Alzheimer's. These oligomers accumulate before clinical diagnosis and are believed to trigger synaptic dysfunction and neurodegeneration. Acumen is currently evaluating sabirnetug in the Phase 2 ALTITUDE trial, assessing its clinical efficacy and safety in patients with early AD. A Phase 1 study is also underway to evaluate a subcutaneous formulation of the drug in healthy volunteers.
Details of the Expanded Collaboration
Under the extended agreement, Lonza will manufacture cGMP DP of sabirnetug for ongoing and future clinical phases, with the potential to support commercial launch from its DP manufacturing facility in Visp, Switzerland. Lonza will also provide quality control and stability testing services.
“Our team of experts has extensive experience in supporting the clinical and commercial manufacture of drug products,” said Peter Droc, head of drug product services, Lonza. “In line with our strategy to offer an integrated end-to-end offering for biologics manufacturing, we are looking forward to collaborating with Acumen to advance its innovative and promising drug candidate in the clinic and beyond.”
Clinical Development and Future Prospects
James Doherty, president and chief development officer, Acumen Pharmaceuticals, noted, “The extension of our collaboration comes at a time when we’re advancing our clinical programs for sabirnetug with more than 50 Phase 2 sites activated across the U.S., Canada, U.K. and EU. We look forward to continuing our work with Lonza and delivering a potential next-generation treatment for early Alzheimer’s disease.”
With over 55 million people worldwide living with dementia, and Alzheimer's disease accounting for 60-70% of these cases, the need for effective treatments is urgent. Sabirnetug represents a potential advancement in targeting the underlying pathology of Alzheimer's disease at its earliest stages.
