Anavex Life Sciences announced the total enrollment of 92 patients with Rett syndrome for the ANAVEX2-73 EXCELLENCE Phase 2/3 study in Rett syndrome patients ages greater than or equal to 5 years to 17. This exceeds the original enrollment target and the Company expects to announce topline results from this study in 2H 2023. ANAVEX2-73 is an orally available, small-molecule activator of the sigma-1 receptor which, data suggest, is pivotal to restoring neural cell homeostasis and promoting neuroplasticity. The enrollment completion of the randomized, placebo-controlled EXCELLENCE Phase 2/3 study ANAVEX2-73-RS-003 for the treatment of pediatric patients with Rett syndrome was preceded by the successful completion of both placebo-controlled Phase 2 U.S., and Phase 3 AVATAR studies in adult patients with Rett syndrome. The multi-center, double-blind clinical EXCELLENCE study in pediatric patients is measuring safety, tolerability, and efficacy of daily oral ANAVEX2-73 doses or placebo. After completing the double-blind study, eligible participants are able to join a voluntary open-label extension study of ANAVEX2-73.
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