Swedish biopharmaceutical company Alzinova AB (publ) has reached a significant milestone in the development of its Alzheimer's disease vaccine candidate ALZ-101, announcing the successful release of the drug substance required for its upcoming Phase 2 clinical trial. This achievement paves the way for final drug product manufacturing, with the study set to commence in the second half of 2025.
The drug substance was manufactured by Polypeptide Laboratories in Strasbourg, France, adhering to Good Manufacturing Practice (GMP) standards essential for pharmaceutical production. The companies will continue their collaboration to refine and optimize the manufacturing process in preparation for late-stage clinical trials, with a focus on enhancing production efficiency, ensuring scalability, and meeting regulatory requirements.
"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!" said Stephane Varray, Chief Commercial Officer of PolyPeptide Group.
Promising Phase 1b Results Support Advancement
The progression to Phase 2 follows recently completed Phase 1b clinical trial results that exceeded expectations. The study, which included patients with early Alzheimer's disease, successfully met its primary and secondary objectives of safety, tolerability, and immunogenicity.
"The results exceeded our expectations for a Phase 1b clinical trial. Although the study was designed to evaluate the safety, tolerability and immunogenicity of ALZ-101, we are already seeing clear trends suggesting a clinically meaningful treatment effect," said Tord Labuda, CEO of Alzinova.
The Phase 1b trial demonstrated that ALZ-101 has a favorable safety profile with primarily mild side effects. The most common adverse reactions were injection-related events such as pain, redness, tenderness, and heat at the injection site. The incidence of Amyloid-Related Imaging Abnormalities - Hemorrhagic (ARIA-H) was comparable between active treatment and placebo groups.
Strong Immune Response and Disease Stabilization
A key finding from the Phase 1b study was ALZ-101's ability to generate a robust immune response against toxic amyloid-beta oligomers, which are believed to play a central role in Alzheimer's disease pathology. Patients who received ALZ-101 developed high and persistent antibody levels, with evidence suggesting a long-lasting immune response.
Notably, the exploratory endpoints revealed that most patients receiving active treatment showed no clinical deterioration during the study period, which lasted between 100 and 140 weeks on average. This suggests potential benefit in slowing disease progression compared to other amyloid-beta targeted treatments, though larger studies are needed to confirm this hypothesis.
Measurements of neurofilament light (NFL), a biomarker of neuronal damage, showed a trend toward lower values in patients who received ALZ-101 compared to those who initially received placebo, consistent with a possible slowing of the neurodegenerative process.
"ALZ-101 has now been tested in humans for the first time with positive results. It is gratifying to see that more pieces of the puzzle are falling into place and indicating a mechanism of action in Alzheimer's disease that no other treatment has shown," noted Anders Sandberg, CSO for Alzinova.
Novel Approach to Alzheimer's Treatment
ALZ-101 represents a distinct approach to Alzheimer's disease treatment. Unlike therapies that target amyloid plaques, ALZ-101 is designed to specifically target toxic amyloid-beta oligomers. The vaccine did not cause neuroinflammation or alter plaque pathology in the Phase 1b study, demonstrating its specificity.
Henrik Zetterberg, Professor of Neurochemistry at the University of Gothenburg, who was involved in the biomarker analysis of the study, commented: "The strong safety and immunogenicity profile of ALZ-101, together with early signs of a clinically meaningful effect, highlights its potential as a distinct and promising therapy for Alzheimer's disease."
Global Impact and Company Focus
Alzheimer's disease affects approximately 40 million people globally and remains one of the most common and devastating neurological diseases. Alzinova's patented AβCC peptide technology enables the development of disease-modifying treatments that precisely target toxic amyloid-beta oligomers.
In addition to ALZ-101, the company is developing the antibody ALZ-201, which is currently in preclinical development, as part of its strategy to expand its pipeline of potential Alzheimer's treatments.
The upcoming Phase 2 clinical trial will be crucial in further evaluating ALZ-101's efficacy and confirming the promising results observed in the Phase 1b study. With the successful release of the drug substance, Alzinova is well-positioned to advance this potentially groundbreaking therapeutic vaccine for Alzheimer's disease.
