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Anavex Life Sciences Announces Preliminary Clinical Efficacy Data of its U.S. Phase 2 Clinical Trial of ANAVEX®2-73 in Patients with Rett Syndrome
Both global efficacy endpoints, RSBQ and CGI-I, showed significant improvement with respect to baseline after 7 weeks of treatment with ANAVEX®2-73
About this update from Anavex Life Sciences Corp.
[{"type":"text","content":"Both global efficacy endpoints, RSBQ and CGI-I, showed significant improvement with respect to baseline after 7 weeks of treatment with ANAVEX®2-73 (blarcamesine)ANAVEX®2-73 (blarcamesine) treatment effect was significantly correlated with changes in two different biomarkers linked to the neurobiology of Rett syndrome, Glutamate and GABADetailed Data to be Presented at 6th Annual European Rett Syndrome Conference in Tampere, Finland, September 27-28, 2019 NEW YORK, Sept. 16, 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) disorders, today announced preliminary clinical data of the U.S. Phase 2 Rett syndrome clinical trial.\n Preliminary Clinical Data is derived from the ANAVEX®2-73-RS-001 study on the first 6-patient cohort ranging in age from 18 to 36 years who completed the pharmacokinetic (PK) part of the study and who received a low dose of approx. 5 mg daily oral liquid dose of ANAVEX®2-73 (blarcamesine) for 7 weeks. Patients are continuing participation in the ANAVEX®2-73-RS-001 open label extension study. Both efficacy endpoints, the Rett Syndrome Behaviour Questionnaire (RSBQ) and the Clinical Global Impression – Improvement (CGI-I) showed significant improvement with respect to baseline after 7 weeks of treatment. The RSBQ Total average scores improved from 50 to 34 points (2-tailed Wilcoxon signed rank test, p = 0.027) and the CGI-I scores were positively correlated with RSBQ Total scores at 7 weeks (2-tailed Spearman’s rho = 0.956, p = 0.003). Supporting the clinical assessments, plasma levels of the biomarker Glutamate also decreased significantly (Week 0 vs. Week 7; 2-tailed Wilcoxon signed rank test, p = 0.046) and levels of Glutamate at Week 7 were directly correlated with CGI-I scores at Week 7 (2-tailed Spearman’s rho = 0.837, p = 0.038) with greater decreases in Glutamate associated with greater improvement in these efficacy scores. Glutamate is the main excitatory neurotransmitter in the brain and is known to be higher in patients with Rett syndrome compared to healthy subjects in the brain, as measured by ma...