Anavex Life Sciences Corp., a clinical-stage biopharmaceutical company, has announced the submission of a Marketing Authorization Application (MAA) for its lead drug candidate, blarcamesine, to the European Medicines Agency (EMA) for the treatment of Alzheimer’s disease (AD). Blarcamesine is a small molecule administered orally once daily. It exerts its effects by targeting the Sigma-1 receptor (SIGMAR1) and muscarinic receptors in the brain. Results from the Phase 2/3 trial of blarcamesine were presented at the 2024 Clinical Trials in Alzheimer’s Disease conference, outlining the findings from over 500 participants enrolled at sites in Australia, Canada and the UK. Participants received a daily dose of 30mg or 50mg blarcamesine, or a placebo, for a period of 48 weeks. While no significant changes were observed on the functional ADCS-ADL scale, results presented at CTAD showed that participants receiving a 50mg daily dose of blarcamesine exhibited 38.5% slower clinical decline as measured on the ADAS-Cog13 scale of cognitive function. The drug also had a tolerable safety profile (mild dizziness and fatigue was reported by 13% of participants receiving the 30mg dose) and does not require routine MRI monitoring. Read the company press release: