{"id":789950,"date":"2023-10-12T10:52:13","date_gmt":"2023-10-12T14:52:13","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/annovis-bio-announces-positive-interim-independent-analysis-for-statistical-power-in-its-alzheimers-study\/"},"modified":"2023-10-12T10:52:13","modified_gmt":"2023-10-12T14:52:13","slug":"annovis-bio-announces-positive-interim-independent-analysis-for-statistical-power-in-its-alzheimers-study","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/annovis-bio-announces-positive-interim-independent-analysis-for-statistical-power-in-its-alzheimers-study\/","title":{"rendered":"Annovis Bio Announces Positive Interim Independent Analysis for Statistical Power in Its Alzheimer\u2019s Study"},"content":{"rendered":"

\nPre-specified, blinded interim analysis for sample size re-estimation indicates that the ongoing Phase 2\/3 study in Alzheimer\u2019s Disease (AD) is sufficiently powered to continue as planned without any additional patients
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BERWYN, Pa., Oct. 12, 2023 (GLOBE NEWSWIRE) — Annovis Bio, Inc.<\/u><\/a>\u00a0(NYSE: ANVS) (“Annovis” or the “Company”), a clinical-stage drug platform company addressing neurodegenerative diseases, today 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\u2019s co-primary endpoints are the change from baseline to the end of treatment of Alzheimer\u2019s Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog11) and Alzheimer\u2019s Disease Cooperative Study Clinician\u2019s Global Impression of Change (ADCS-CGIC), which assess cognition and activities of daily living.<\/p>\n

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.<\/p>\n

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.<\/p>\n

Maria L. Maccecchini, Ph.D., Founder, President, and CEO of Annovis, commented: \u201cAlthough we remain blinded to the data, results from this interim analysis supports our original statistical powering for enrolling 320 patients into the Phase 2\/3 Alzheimer\u2019s study. Therefore, sample size re-estimation for the study is not necessary, which in our view, may signal an emerging positive treatment effect in patients receiving buntanetap versus those receiving placebo after just 6 weeks of treatment. While the interim analysis does not mean that the trial will necessarily be successful, it does mean that the trial is powered for potential success.\u201d<\/p>\n

Update and projections of our ongoing activities:<\/p>\n

Alzheimer\u2019s disease<\/p>\n