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Anavex Provides Corporate Update, Announces Completion of Clinical Conduct of ADME and DDI Clinical Studies

AVXL
  • Anavex Life Sciences Corp. completed clinical conduct of Drug-drug Interaction (DDI) and Absorption, Distribution, Metabolism and Excretion (ADME) studies for blarcamesine in healthy volunteers.
  • The DDI study enrolled 65 participants receiving 30 mg of blarcamesine, concluding late September with no reported serious adverse events.
  • The ADME study enrolled 8 participants receiving 30 mg of blarcamesine, concluding mid-October with no reported serious adverse events.
  • The U.S. Food and Drug Administration (FDA) cleared the Investigational New Drug (IND) application for blarcamesine in Fragile X syndrome.
  • Anavex has an upcoming November meeting with the FDA to discuss adding pediatric participants to the Phase 3 Rett syndrome study.
  • Blarcamesine has received Orphan Drug Designation from the FDA for both Rett syndrome and Fragile X syndrome indications.
  • Data from the completed pharmacology studies align with recommendations from the FDA and the European Medicines Agency (EMA) to support development programs.
  • Study start-up activities are underway for both the Rett syndrome Phase 3 program and the Fragile X syndrome program.