Anavex’s Blarcamesine Shows Promise in Slowing Alzheimer’s Progression in Phase 2b/3 Trial; Shares up 9%
Anavex Life Sciences (Nasdaq: AVXL) presented data at the 2024 Clinical Trials on Alzheimer’s Disease (CTAD) conference from their Phase 2b/3 trial of blarcamesine (ANAVEX®2-73) in early Alzheimer’s disease (AD) patients. The trial results indicate that the once-daily oral drug met pre-specified efficacy criteria, showing slowed clinical decline and a favorable safety profile without neuroimaging-related side effects. AVXL shares are currently trading up 9%.
The study demonstrated that blarcamesine slowed disease progression by 36.3% in the general trial population, with a stronger effect (49.8% slower progression) in patients with the common SIGMAR1 gene variant, suggesting a possible genetic basis for treatment response. Blarcamesine’s mechanism of action, involving SIGMAR1 activation, supports autophagy—a process that helps maintain cellular balance by clearing protein aggregates linked to neurodegeneration. This unique action could offer a complementary or alternative approach to existing Alzheimer’s treatments.
Christopher U. Missling, PhD, CEO of Anavex commented, “Alzheimer’s disease is such a devastating disease that affects tens of millions worldwide. We believe, the clinically meaningful study results provide the potential for patients and their families to have a better and longer quality of life. We believe the scalable and convenient features of blarcamesine could reduce crucial barriers within the currently complex healthcare ecosystem for Alzheimer’s disease and provide broader access to a diverse population with early Alzheimer’s disease.”
The study also reported that blarcamesine’s once-daily oral formulation could provide an accessible option for AD management, potentially easing healthcare delivery challenges and broadening patient access. Anavex plans to submit the drug for regulatory review in Europe (EMA) by the end of 2024.
Earlier this month, the Company reported encouraging preliminary biomarker results from its ongoing phase 2 study of ANAVEX®3-71 for the treatment of schizophrenia.
