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 really appreciate Alzinova's trust in PolyPeptide and are proud to be their partner in the manufacturing of ALZ-101 for this important milestone. We are excited to be on this journey with Alzinova and are looking forward to celebrating future milestones together!", says Stephane Varray, Chief Commercial Officer, PolyPeptide Group
For more information, please contact:
Tord Labuda, CEO
E-mail: info@alzinova.com
About Alzinova AB
Alzinova AB is a Swedish biopharmaceutical company in clinical development specializing in the treatment of Alzheimer's disease, where the starting point is to attack toxic amyloid-beta oligomers. The lead candidate ALZ-101 is a therapeutic vaccine against Alzheimer's disease. Alzinova's patented AßCC peptide technology makes it possible to develop disease-modifying treatments that target the toxic amyloid-beta oligomers that are central to the onset and development of the disease with great accuracy. From a global perspective, Alzheimer's disease is one of the most common and devastating neurological diseases, with around 40 million affected today. Based on the same technology, the company is also developing the antibody ALZ-201, which is currently in preclinical development, and the goal is to further expand the pipeline. The company's Certified Adviser on Nasdaq First North Growth Market is Mangold Fondkommission AB. For more information about Alzinova, please visit: www.alzinova.com
