Anavex announced that it has enrolled the first patient in its Phase 2b/3 double-blind, randomized, placebo-controlled, 48-week safety and efficacy trial of Anavex2-73 for the treatment of early Alzheimer’s disease. The Phase 2b/3 study will enroll approximately 450 patients, randomized 1:1:1 to two different Anavex2-73 doses or placebo. As part of the planned international study, North American sites will be added. The Anavex2-73 Phase 2b/3 study design incorporates genomic precision medicine biomarkers identified in the Anavex2-73 Phase 2a study. Primary and secondary endpoints will assess safety and both cognitive and functional efficacy, measured through ADAS-Cog, ADCS-ADL and CDR-SB. Anavex2-73 Phase 2a Alzheimer’s disease study previously demonstrated dose dependent improvement in exploratory endpoints of cognition, or MMSE and function, or ADCS-ADL.
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