Alzinova AB (publ) (ticker: ALZ) announces that another milestone in the development of the company's vaccine candidate ALZ-101 for Alzheimer's disease has been reached. All study participants have now completed the final visit in the phase 1 study. All data points will now be processed, analyzed and compiled. The final results for the entire study period are planned to be communicated by the end of March 2025.
"It is with great pleasure that we can announce that all study participants, after about three years of participation, have now completed their last visits to the study. It is also with gratitude that we can state that 100% of the participants who were included in the extension part also completed the study. A great tribute to these participants who have been involved and contributed to the continued development of our vaccine candidate", says Alzinova's CEO Tord Labuda.
About the Phase 1b study
The Phase 1b study has now been completed. All data points will now be processed, analyzed and compiled. The primary objective of the study is to evaluate the safety and tolerability of repeated dosing of the ALZ-101 vaccine candidate in patients with early Alzheimer's disease. The study also includes secondary and exploratory endpoints related to immune response and biomarkers.
The Phase 1b study includes a total of 32 patients with early Alzheimer's disease. The study has examined three different dose strengths of ALZ-101, 125, 250 and 400 µg as well as placebo. In one Part A of the study, 26 of the patients were treated double-blind and randomized with the ALZ-101 vaccine in doses of 125 µg or 250 µg, and six patients with placebo.
The study was expanded with an extension part (part B), which meant that all patients were offered active treatment with 250 µg ALZ-101 over a 20-week period and with an additional 48 weeks follow-up. The primary purpose of the B part is to provide information on long-term safety and tolerability, the long-term immune response, and information on the effect on biomarkers and cognitive functions.
The study was further expanded to investigate whether higher dose, 400 µg ALZ-101, has the same safety and tolerability as lower doses, and whether secondary endpoints are met to a greater extent. Six patients were enrolled in this treatment arm and were treated on four occasions at the same intervals as in the other groups. These patients were followed for a total of 20 weeks.
For further 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
