On 13 October, Anavex Life Sciences Corp - a clinical-stage biopharmaceutical company developing therapeutics for the treatment of neurodegenerative diseases including Alzheimer’s disease (AD) – announced that the Independent Data Safety Monitoring Board (DSMB) has completed its pre-planned review of its Phase IIb/III study of ANAVEX2-73 (blarcamesine) for AD. The DSMB reviewed the interim safety data for the ANAVEX2-73 Phase IIb/III clinical study and its Open Label Extension ANAVEX2-73-AD-EP-004 ATTENTION-AD study. Upon review of the interim safety data, the DSMB recommended the continuation of the studies without modification.
The Phase IIb/III ANAVEX2-73-AD-004 clinical study is a double-blind, randomised, placebo-controlled and 48-week trial evaluating the safety and efficacy of ANAVEX2-73 for the treatment of early AD. The trial enrolled 509 participants, who received either two different ANAVEX2-73 doses or placebo. Primary and secondary endpoints will assess safety and both cognitive and functional efficacy, measured through ADAS-Cog, ADCS-ADL and CDR-SB. ANAVEX2-73-AD-EP-004 is the 96-week open label extension of the placebo-controlled Phase IIb/III ANAVEX2-73 study. The company anticipates topline data in the second half of 2022.
