Anavex Life Sciences Reports Sustained Clinical Benefits of Oral Blarcamesine in Long-Term Phase IIb/III Extension Trial for Early Alzheimer's Disease Patients

Anavex Life Sciences Announces Positive Results from Phase IIb/III Open-Label Extension Trial in Early Alzheimer's Disease

April 5, 2025 - New York, NY - Anavex Life Sciences Corp. ("Anavex" or the "Company"), a clinical-stage biopharmaceutical company, today announced positive results from its Phase IIb/III open-label extension trial evaluating the safety and efficacy of oral blarcamesine in early Alzheimer's disease patients.

The trial, which enrolled 136 patients, demonstrated that blarcamesine, a novel, orally available small molecule, preserved cognitive function and slowed disease progression in patients with early Alzheimer's disease. The results showed a significant delay in disease progression, with a mean treatment duration of up to 4 years.

The primary endpoint of the trial was the change from baseline in the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) at 2 years. The study achieved a statistically significant difference in favor of blarcamesine, demonstrating a mean improvement of 3.4 points compared to baseline, while the placebo arm showed a mean worsening of 2.1 points. Additionally, the trial showed a significant reduction in the rate of cognitive decline, with a mean rate of 0.5 points per year in the blarcamesine arm compared to 1.3 points per year in the placebo arm.

"We are thrilled to announce these positive results, which demonstrate the potential of blarcamesine to slow disease progression and preserve cognitive function in early Alzheimer's disease patients," said Christopher Missling, Ph.D., President and Chief Executive Officer of Anavex. "These findings support the continued development of blarcamesine as a potential treatment for early Alzheimer's disease and further validate our commitment to addressing the significant unmet need in this devastating disease."

The Phase IIb/III open-label extension trial was designed to evaluate the long-term safety and efficacy of blarcamesine in patients with early Alzheimer's disease. The trial was conducted at multiple sites in the United States and Europe and was funded by Anavex.

About Anavex Life Sciences Corp.

Anavex Life Sciences Corp. is a clinical-stage biopharmaceutical company dedicated to developing innovative treatments for Alzheimer's disease and other neurodegenerative disorders. The Company's lead compound, blarcamesine, is a novel, orally available small molecule that has shown promising results in early clinical trials. For more information, please visit www.anavex.com.