Acumen Pharmaceuticals Expands Lonza Partnership for Sabirnetug Manufacturing for Early Alzheimer's

Acumen Pharmaceuticals, Inc., a clinical-stage biopharmaceutical firm listed on NASDAQ under the ticker ABOS, has announced an extension of its collaboration with Lonza, a leading global provider of integrated healthcare solutions. The partnership aims to support the potential commercial launch of Acumen's promising Alzheimer's treatment, sabirnetug (ACU193), which is currently in clinical trials.

Sabirnetug is the first humanized monoclonal antibody to show clinical efficacy in selectively targeting toxic soluble amyloid beta oligomers (AβOs) in Alzheimer's disease (AD) patients. These oligomers are highly toxic forms of amyloid beta that accumulate before clinical diagnosis and are key contributors to synaptic dysfunction and neurodegeneration. Acumen believes that sabirnetug could be a groundbreaking antibody treatment for early-stage AD. Presently, the company is enrolling patients for the ALTITUDE study, a Phase 2 clinical trial assessing the efficacy and safety of intravenous sabirnetug in early AD patients. Additionally, a Phase 1 study is comparing a subcutaneous formulation of the drug in healthy volunteers.

The extended collaboration builds upon a previously successful relationship between Acumen and Lonza. Under the new terms, Lonza will not only continue to provide drug substance (DS) manufacturing for sabirnetug's Phase 2 clinical supply but will also handle current Good Manufacturing Practice (cGMP) drug product (DP) manufacturing. This will include support for both ongoing and future clinical phases and the potential commercial release of the drug. The manufacturing will take place at Lonza's state-of-the-art facility in Visp, Switzerland, and will also include quality control and stability testing.

Peter Droc, Head of Drug Product Services at Lonza, expressed confidence in their continued partnership with Acumen. He emphasized Lonza's extensive expertise in supporting both clinical and commercial drug manufacturing and expressed excitement about advancing Acumen’s innovative drug candidate.

James Doherty, President and Chief Development Officer at Acumen Pharmaceuticals, highlighted that the collaboration extension comes at a crucial time. With over 50 Phase 2 trial sites activated across the U.S., Canada, the U.K., and the European Union, Acumen is moving forward robustly with its clinical programs for sabirnetug. Doherty expressed optimism about the collaboration with Lonza, aiming to deliver a next-generation treatment for early Alzheimer’s disease.

Sabirnetug, also known as ACU193, is a humanized monoclonal antibody specifically designed to target soluble amyloid beta oligomers, which are notably more toxic and pathogenic compared to amyloid beta monomers and plaques. Soluble AβOs are known to be potent neurotoxins that bind to neurons, disrupt synaptic function, and lead to neurodegeneration. By targeting these toxic oligomers, sabirnetug aims to address one of the root causes of the neurodegenerative process in Alzheimer's disease. The U.S. Food and Drug Administration has granted Fast Track designation for sabirnetug for the treatment of early AD, and it is currently being evaluated in a Phase 2 clinical trial in patients with early AD.

Acumen Pharmaceuticals is focused on developing novel therapeutics targeting toxic soluble amyloid beta oligomers for Alzheimer's disease. The company's scientific founders have been pioneers in researching AβOs, which evidence suggests are early and persistent triggers of Alzheimer's pathology. Sabirnetug, Acumen’s lead investigational product candidate, is currently in a Phase 2 clinical trial known as ALTITUDE-AD, following promising results from an earlier Phase 1 trial. The company is headquartered in Newton, Massachusetts.