Business
Acumen Pharmaceuticals Extends Collaboration with Lonza to Add Drug Product Manufacturing of Sabirnetug for Early Alzheimer’s Disease
Agreement builds upon a successful collaboration supporting the manufacture of sabirnetug (ACU193) drug substance (DS) for clinical studies in Alzheimer’s
About this update from Acumen Pharmaceuticals, Inc.
[{"type":"text","content":"Agreement builds upon a successful collaboration supporting the manufacture of sabirnetug (ACU193) drug substance (DS) for clinical studies in Alzheimer’s diseaseExtension to provide drug product (DP) manufacturing services for clinical and potential commercial supply from Lonza’s Visp, Switzerland site NEWTON, Mass., and BASEL, Switzerland, Sept. 26, 2024 (GLOBE NEWSWIRE) -- Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS), a clinical-stage biopharmaceutical company developing a novel therapeutic that targets toxic soluble amyloid beta (Aβ) oligomers (AβOs) for the treatment of Alzheimer’s disease (AD), announced today that it has extended its collaboration with Lonza to enable the potential future commercial launch of sabirnetug (ACU193). Sabirnetug is the first humanized monoclonal antibody to clinically demonstrate selective target engagement of AβOs in AD patients. Soluble AβOs are a highly toxic form of Aβ that begin to accumulate before a clinical diagnosis of AD and are an early and persistent trigger of synaptic dysfunction and neurodegeneration. Acumen is developing sabirnetug as a potential next generation antibody treatment for early AD. Acumen is currently enrolling patients in the ALTITUDE sabirnetug -AD study, a Phase 2 clinical trial designed to evaluate the clinical efficacy and safety of intravenous sabirnetug in patients with early AD. Acumen is also evaluating a subcutaneous formulation of sabirnetug in a Phase 1 pharmacokinetic comparison study in healthy volunteers. The extended collaboration builds upon an existing successful relationship between the two companies, in which Lonza provides DS manufacturing for the Phase 2 clinical supply of sabirnetug. Under the terms of the extended agreement, Lonza will manufacture cGMP DP of sabirnetug for the ongoing and future clinical phases and support the potential commercial launch at its industry-leading state-of-the-art DP manufacturing facility in Visp, Switzerland. Lonza will also provide quality control and stability testing as part of the collaboration. Peter Droc, Head of Drug Product Services, Lonza, commented: “Our team of experts has extensive experience in supporting the clinical and commercial manufacture of drug products. In line with our strategy to offer an integrated end-to-end offering for biologics manufacturing, we are looking forward to collaborating...