Key Highlights:
- Acumen Pharmaceuticals extends its collaboration with Lonza to add drug product manufacturing for early Alzheimer’s disease.
- The agreement builds upon a successful collaboration supporting the manufacture of sabirnetug (ACU193) drug substance (DS) for clinical studies in Alzheimer’s disease.
- Lonza will manufacture cGMP DP of sabirnetug for the ongoing and future clinical phases and support the potential commercial launch at its DP manufacturing facility in Visp (CH).
Acumen Pharmaceuticals, 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 that it has extended its collaboration with Lonza to enable the potential future commercial launch of sabirnetug (ACU193).
Sabirnetug is the first humanised 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 DP manufacturing facility in Visp (CH). 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 with Acumen to advance its innovative and promising drug candidate in the clinic and beyond.”
James Doherty, president and chief development officer, Acumen Pharmaceuticals, added: “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.”