Anavex Life Sciences Corp. shares were down 11% to $10.78 Monday following a 36% jump Friday that was fueled by positive topline results from the Phase 2b/3 clinical trial of oral Anavex2-73 blarcamesine for the treatment of early Alzheimer’s disease.
The stock is up 17% in the past three months.
The biopharmaceutical company said Friday that Anavex2-73 met the primary endpoints and key secondary endpoints with statistically significant results.
The next step is to meet with regulatory authorities to discuss the treatment’s ongoing development, with an aim to bring it to patients in Europe, Asia-Pacific and the U.S., the company said.
The placebo-controlled 509-patient Phase 2b/3 trial was conducted over 48 weeks, during which primary endpoints were hit and the treatment was shown to reduce clinical decline in the intent-to-treat population. An open-label extension study will continue to follow participants over a 96-week period.
The company said Anavex2-73 demonstrated visible improvement in patients, who were 84% more likely to have improved cognition, by ADAS-Cog score change of -0.50 points or better from baseline, to end of treatment than patients on placebo.
The treatment also met the secondary endpoint of reduction in clinical decline of cognition and function assessed by the Clinical Dementia Rating Scale Sum of Boxes, representing 27% reduction in the ITT population. It was generally safe and well tolerated, the company said.