Anavex Life Sciences Doses First Patient in Phase 2 Clinical Trial of ANAVEX®2-73 for the Treatment of Rett Syndrome

Anavex Life Sciences (NASDAQ:AVXL) has announced it has dosed its first patient in its AVATAR Phase 2 trial of ANAVEX2-73 to treat Rett syndrome.

As quoted in the press release:

ANAVEX®2-73 has already received orphan drug designation from the FDA for the treatment of Rett syndrome.

Terence J. O’Brien, MB, BS, MD, FRACP, FRCPE, FAHMS, FAES, principal investigator of the AVATAR study and Van Cleef Roet Professor of Medicine (Neurology) and Head, Department of Neuroscience & Deputy Head, Central Clinical School, Monash University as well as Program Director – Alfred Brain, Director of Neurology & Deputy Director of Research, Alfred Health stated, ”Rett syndrome is a devastating disease for patients and families, for which there are currently no treatments that improve the course of the disease. There is an urgent need for high quality, evidence-based treatments for Rett syndrome patients.”

“We are excited to announce the first patient dosed in our AVATAR trial of ANAVEX®2-73 for Rett syndrome,” said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. “We have made great effort to develop a patient-centric clinical trial, using our learnings from broad dialogue with the Rett syndrome community.”

The Phase 2 study, AVATAR, is a randomized double-blind, placebo-controlled study to evaluate the safety and efficacy of oral liquid ANAVEX®2-73 formulation to treat Rett syndrome. Eligible patients with will be randomized to receive once daily oral liquid ANAVEX®2-73 (combined-active group, 18 patients) or placebo (12 patients) for up to 7 weeks (the placebo-controlled period of the trial) including ANAVEX®2-73-specific genomic precision medicine biomarkers. The study will enroll approximately 30 patients aged 18 or higher, and is being run at the Clinical Trials Units of The Alfred and the Royal Melbourne Hospitals in Victoria, Australia. All patients who participate in the study will be eligible to receive ANAVEX®2-73 under a voluntary open label extension protocol. This study is part of an Anavex Rett syndrome program including further studies of ANAVEX®2-73, among them an ongoing Phase 2 study in the US¹.

Click here to read the full press release.