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Msg  3777 of 3782  at  2/2/2023 7:13:57 AM  by



Anavex Life Sciences Announces Exceeding of Enrollment Target for the ANAVEX(R)2-73 (blarcamesine) EXCELLENCE Phase 2/3 Rett Syndrome Clinical Trial

7:00 am ET February 2, 2023 (Globe Newswire) Print
GlobeNewswireFebruary 02, 2023

NEW YORK, Feb. 02, 2023 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. ("Anavex" or the "Company") (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer's disease, Parkinson's disease, Rett syndrome and other central nervous system (CNS) diseases, today announced the total enrollment of 92 patients with Rett syndrome for the ANAVEX(R)2-73 (blarcamesine) EXCELLENCE Phase 2/3 study in Rett syndrome patients ages greater-than or equal to 5 years to 17 (inclusive). This exceeds the original enrollment target and the Company expects to announce topline results from this study in 2H 2023.

ANAVEX(R)2-73 is an orally available, small-molecule activator of the sigma-1 receptor (SIGMAR1) which, data suggest, is pivotal to restoring neural cell homeostasis and promoting neuroplasticity.1

The enrollment completion of the randomized, placebo-controlled EXCELLENCE Phase 2/3 study ANAVEX(R)2-73-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. (ANAVEX(R)2-73-RS-001)2, and Phase 3 AVATAR (ANAVEX(R)2-73-RS-002)3 studies in adult patients with Rett syndrome.

The multi-center, double-blind clinical EXCELLENCE study (ANAVEX(R)2-73-RS-003)4 in pediatric patients is measuring safety, tolerability, and efficacy of daily oral ANAVEX(R)2-73 doses or placebo. After completing the double-blind study, eligible participants are able to join a voluntary open-label extension study of ANAVEX(R)2-73. In communication with the FDA, we received their input on the endpoints, which were utilized in this study.

ANAVEX(R)2-73 (blarcamesine) had previously received Fast Track designation, Rare Pediatric Disease designation and Orphan Drug designation from the FDA for the treatment of Rett syndrome.

"Rett syndrome is a devastating, non-inherited genetic post-natal progressive neurodevelopmental disorder that occurs almost exclusively in girls and leads to severe impairments, affecting nearly every aspect of the child's life," said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. "We are excited to complete enrollment in this multicenter study with ANAVEX(R)2-73 in Rett syndrome and look forward to reporting the results later this year."


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