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Anavex completes ADME and DDI studies for blarcamesine; FDA clears IND for Fragile X
AVXLAnavex Life Sciences Corp.
Anavex Life Sciences completed clinical conduct of two pharmacology studies for its lead drug candidate, blarcamesine: a Drug-drug Interaction (DDI) study with 65 participants and an Absorption, Distribution, Metabolism and Excretion (ADME) study with eight healthy volunteers. Preliminary observations reported no serious adverse events in either trial. Additionally, the U.S. Food and Drug Administration cleared the company's Investigational New Drug application for blarcamesine in Fragile X syndrome, allowing study start-up activities to proceed. The company also announced an upcoming FDA meeting in November regarding adding pediatric participants to its Phase 3 Rett syndrome study. Anavex is a clinical-stage biopharmaceutical company developing treatments for central nervous system diseases.