Press release
Anavex Life Sciences Reports the Results of Review by the Independent Data Safety Monitoring Board for its Phase 2/3 Trials of ANAVEX®2-73 in Patients with Rett Syndrome
NEW YORK, April 12, 2021 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company
About this update from Anavex Life Sciences Corp.
[{"type":"text","content":"NEW YORK, April 12, 2021 (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 that the Independent Data Safety Monitoring Board (DSMB) for the Company's ongoing clinical trial program, including the late stage AVATAR (ANAVEX®2-73-RS-002)1, EXCELLENCE (ANAVEX®2-73-RS-003)2 and the U.S. Rett syndrome extension study (ANAVEX®2-73-RS-EP-001) of its investigational compound ANAVEX®2-73 (blarcamesine) has completed its recent pre-planned review of the respective interim safety data for these three separate clinical studies. Upon review of the interim safety data, the DSMB made the following recommendation for the randomized, double-blind, placebo-controlled AVATAR (ANAVEX®2-73-RS-002) study in adult patients with Rett syndrome: The DSMB recommendation is to continue the studies without modification. Upon review of the interim safety data, the DSMB made the following recommendation for the randomized, double-blind, placebo-controlled EXCELLENCE (ANAVEX®2-73-RS-003) study in pediatric patients with Rett syndrome: The DSMB recommendation is to continue the studies without modification. Upon review of the interim safety data, the DSMB made the following recommendation for the open-label extension U.S. Rett syndrome (ANAVEX®2-73-RS-EP-001) study in adult patients with Rett syndrome: The DSMB recommendation is to continue the studies without modification. DSMBs are committees commonly used in clinical trials to protect the interests of the patients and the integrity of the study data in ongoing trials. Based on the previously reported results of the first placebo-controlled U.S. Phase 2 (ANAVEX®2-73-RS-001)3 study in adult patients with Rett syndrome, Anavex is planning to meet with the FDA to discuss the approval pathway. There are no FDA-approved drugs for Rett syndrome. ANAVEX®2-73 has Fast Track designation, Rare Pediatric Disease designation and Orphan Drug designation from the FDA for the treatment of Rett syndrome and may be considered for accelerated approval. The respective ongoing placebo-controlled Phase 2 and Ph...