Annovis announces interim analysis for statistical power in Alzheimer’s study

Annovis Bio announced that the independent statistical group concluded that its Phase 2/3 AD study was sufficiently powered to continue as originally planned without the addition of patients. This phase 2/3 AD study is designed to enroll a total of 320 mild to moderate AD patients, who are randomly assigned to receive 7.5, 15, 30 mg of buntanetap or placebo once per day. The trial’s co-primary endpoints are the change from baseline to the end of treatment of Alzheimer’s Disease Assessment Scale-Cognitive Subscale 11, ADAS-Cog11, and Alzheimer’s Disease Cooperative Study Clinician’s Global Impression of Change, ADCS-CGIC, which assess cognition and activities of daily living. The Company has received the results of the pre-planned interim analysis conducted by an independent data analytics provider. The interim analysis was based on 107 patients at 6 weeks from all cohorts collectively and showed that the AD trial should continue as planned with the same trial size to maintain the statistical power for both co-primary endpoints. The Company remains blinded to the Phase 3 trial and does not have safety or efficacy data from the trial. A separate safety interim analysis is in process and we expect that interim analysis to be released in two weeks. Update and projections of our ongoing activities: Alzheimer’s disease: to date, 230 patients have been enrolled and 62 have finished the study; safety interim analysis, conducted by the DSMB on October 18, will be released the week of October 23; full enrollment anticipated in November; completion of treatment expected in February 2024; phase 2/3 data expected in March 2024. Parkinson’s disease: to date, 305 patients have finished the study; completion of study expected by the end of November; phase 3 data expected in January 2024.