Alzinova Advances ALZ-101 Development with Drug Substance Release, Paving the Way for Phase 2 Clinical Trial
Sweden, 24 April 2025 – Alzinova AB (publ) (ticker: ALZ) is pleased to announce the release of the drug substance for its upcoming Phase 2 clinical trial of the vaccine candidate ALZ-101 in early Alzheimer’s disease. This milestone enables the production of the final drug product, setting the stage for the study to begin in 2H 2025.
The drug substance was produced by PolyPeptide Laboratories in Strasbourg, France, adhering to the GMP standards required for pharmaceutical manufacturing processes. Alzinova and PolyPeptide Laboratories will continue their partnership to refine and optimize the manufacturing process in preparation for late-stage clinical trials. This collaboration will focus on enhancing production efficiency, ensuring scalability, and meeting stringent regulatory requirements to support the future development and potential commercialization of the vaccine candidate ALZ-101.
”We are very pleased to announce the release of the ALZ-101 drug substance, marking an important milestone in our mission to bring a disease-modifying therapy to Alzheimer’s patients. This achievement reflects the strength of our collaboration with PolyPeptide, whose expertise in GMP manufacturing has been instrumental in advancing our program. We look forward to continuing our partnership as we prepare for the upcoming Phase 2 clinical trial” Tord Labuda, CEO of Alzinova AB