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FDA clears IND for blarcamesine in Fragile X, enabling Phase 2a study
AVXLAnavex Life Sciences Corp.
Anavex Life Sciences Corp. announced that the U.S. Food and Drug Administration has cleared its Investigational New Drug (IND) application for blarcamesine to treat Fragile X syndrome. This regulatory milestone allows the company to proceed with a planned Phase 2a randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, and pharmacokinetics of blarcamesine oral solution in approximately 60 adult males with the condition. The clearance gives Anavex open INDs across all three core indications: Alzheimer’s disease, Rett syndrome, and Fragile X syndrome. Anavex Life Sciences Corp. is a clinical-stage biopharmaceutical company developing treatments for central nervous system diseases.