Anavex Receives FDA IND Clearance for Blarcamesine in Fragile X Syndrome, Enabling Phase 2a Trial

Anavex completed ADME and DDI studies for blarcamesine, with 65 and 8 healthy volunteers respectively, and no serious adverse events reported. The FDA cleared the IND for Fragile X syndrome, and a meeting is scheduled to discuss adding pediatric participants to the Phase 3 Rett syndrome trial.

ANAVEX LIFE SCIENCES CORP. (AVXL) filed an SEC Form 8-K — Other Events. EXHIBIT 99.1 Anavex Provides Corporate Update, Announces Completion of Clinical Conduct of ADME and DDI Clinical Studies Clinical conduct of both blarcamesine (ANAVEX®2-73) studies in healthy volunteers is now complete, data are expected to support clinical pharmacology character

Anavex Life Sciences (AVXL) reported FDA clearance for its drug blarcamesine (ANAVEX 2-73) to advance to human trials for Fragile X syndrome. The company completed clinical pharmacology studies for blarcamesine, with no serious adverse events reported. Anavex also plans to meet with the FDA to discuss adding pediatric participants to its Phase 3 Rett syndrome study.

Anavex Life Sciences (AVXL) received FDA clearance for its Investigational New Drug Application to study blarcamesine in Fragile X syndrome. The Phase 2a trial will assess safety, tolerability, and pharmacokinetics in adult males. Blarcamesine previously received FDA Orphan Drug Designation. AVXL shares closed at $1.48, down 0.67%.

The US FDA cleared Anavex Life Sciences' Investigational New Drug application for blarcamesine to treat Fragile X Syndrome. According to interim CEO Terrie Kellmeyer, this allows a phase 2a clinical trial to proceed.

Anavex Life Sciences received FDA clearance for its Investigational New Drug (IND) application for blarcamesine in Fragile X syndrome. The company plans a Phase 2a study to evaluate the drug's safety, tolerability, and pharmacokinetics in approximately 60 adult males. Blarcamesine has previously received FDA Orphan Drug designation for this indication.