Anavex Life Sciences Announces FDA Approval of IND for Phase 2 Trial of ANAVEX2-73

Anavex Life Sciences (Nasdaq:AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental diseases including Alzheimer’s disease, Rett syndrome and other central nervous system (CNS) diseases, today announced that the Company has received confirmation from the U.S. Food and Drug Administration (FDA) that its Investigational New Drug application (IND) is now open for ANAVEX®2-73 for the treatment of Rett syndrome, a rare and catastrophic neurodevelopmental disease.

As quoted in the press release:

“The acceptance of this IND by the FDA is a significant milestone for ANAVEX®2-73,” stated Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. “This is an important step toward achieving clinical data for the third indication for ANAVEX®2-73 also incorporating genomic precision medicine biomarkers.”

FDA has allowed Anavex to proceed with the Phase 2 study protocol, ANAVEX2-73-RS-001, A Double-Blind, Randomized, Placebo-Controlled, Dose Titration Study of ANAVEX2-73 in Patients with Rett Syndrome using experimental drug ANAVEX®2-73 for the treatment of patients with Rett syndrome. The Phase 2 study is a randomized double-blind, placebo-controlled safety, tolerability, pharmacokinetic and efficacy study of oral liquid ANAVEX®2-73 formulation to treat Rett syndrome. Pharmacokinetic and dose finding will be investigated in a total of 15 patients over a 7-week treatment period including ANAVEX®2-73-specific genomic precision medicine biomarkers. All patients who participate in the study will be eligible to receive ANAVEX®2-73 under a voluntary open label extension protocol. This study will be followed by a planned placebo-controlled safety and efficacy evaluation of ANAVEX®2-73 over a 3 month treatment period.
In addition to Rett syndrome, Anavex has clinical development programs for ANAVEX®2-73 for the treatment of Alzheimer’s disease and Parkinson’s disease dementia.

Click here to read the full press release.