Anavex Life Sciences Reports Recent Data Review by the Independent Data Safety Monitoring Board for its U.S. Phase 2 Clinical Trial of ANAVEX®2-73 in Patients with Rett Syndrome
July 31, 2019 07:00 ET | Source: Anavex Life Sciences Corp.
NEW YORK, July 31, 2019 (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 U.S. Phase 2 Rett syndrome study of its investigational compound ANAVEX®2-73 (blarcamesine) has completed its recent pre-planned review of the preliminary Phase 2 study data.
The DSMB reviewed the preliminary efficacy and safety data for the ANAVEX®2-73 Phase 2 Rett syndrome clinical study ANAVEX®2-73-RS-001.
Upon review of the most recent data, the DSMB made the following recommendation:
The DSMB recommendation is to continue the study 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.
ANAVEX®2-73 has already received orphan drug designation from the FDA as well as a positive opinion for orphan designation from the European Medicines Agency (EMA) for the treatment of Rett syndrome.
About ANAVEX®2-73-RS-001 Clinical Study (ClinicalTrials.gov Identifier: NCT03758924)
The Phase 2 trial is a randomized double-blind, placebo-controlled safety, tolerability, pharmacokinetic and efficacy study of oral liquid ANAVEX®2-73 to treat Rett syndrome. Pharmacokinetic and dose-finding elements in a total of 15 patients over a 7-week treatment period will be evaluated incorporating ANAVEX®2-73-specific genomic precision medicine and other biomarkers. Preceding the placebo-controlled randomization of 15 patients, a 6 patient cohort underwent a 7-week pharmacokinetic (PK) assessment with safety, tolerability, pharmacokinetic and efficacy evaluation of ANAVEX®2-73. All patients who participate in the study will be eligible to receive ANAVEX®2-73 under an open label extension protocol.
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