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news.Acumen Pharmaceuticals has announced the extension of its collaboration with Lonza to facilitate the anticipated commercial launch of sabirnetug, a new therapeutic for early Alzheimer's disease (AD).
Lonza is already involved in the drug substance manufacturing for the Phase II clinical supply of the antibody. Credit: Steve Buissinne from Pixabay.
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Sabirnetug is a humanised monoclonal antibody that has shown selective target engagement with toxic soluble amyloid beta (Aβ) oligomers in patients with AD.
The partnership between Acumen and Lonza will now include the manufacturing of the commercial drug product (DP) of sabirnetug.
This builds on their existing relationship, where Lonza is already involved in the drug substance (DS) manufacturing for the Phase II clinical supply of the antibody.
Under the expanded agreement, Lonza will be responsible for producing the cGMP DP of sabirnetug for ongoing and future clinical trials, as well as for supporting the potential commercial launch.
The manufacturing will take place at Lonza’s advanced DP manufacturing facility in Visp, Switzerland. The collaboration also covers quality control and stability testing services.
Sabirnetug is currently being tested in the ALTITUDE study, a Phase II clinical trial, to evaluate its efficacy and safety in treating patients with early AD.
Additionally, Acumen is assessing a subcutaneous version of the antibody in a Phase I study to compare its pharmacokinetics in healthy volunteers.
Acumen Pharmaceuticals president and chief development officer James Doherty said: “The extension of our collaboration comes at a time when we’re advancing our clinical programmes for sabirnetug with more than 50 Phase II sites activated across the US, Canada, UK and EU.
“We look forward to continuing our work with Lonza and delivering a potential next-generation treatment for early Alzheimer’s disease.”
