BERWYN, PA — Annovis Bio, Inc. (NYSE: ANVS)recently 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 they expect that interim analysis to be released in two weeks.
Maria L. Maccecchini, Ph.D., Founder, President, and CEO of Annovis, commented: “Although 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’s 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.”
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.
In addition to the ongoing clinical studies, Annovis Bio states it is also excited about the novel crystal form of buntanetap – ANVS402. The Company expects to discuss with the FDA the transition buntanetap to ANVS402 and the development of the new form. The bridge studies are expected to be completed in Q1 2024.
As Annovis Bio move forward with its advanced, clinical-stage AD and PD programs, the Company hopes to demonstrate buntanetap’s unique ability to inhibit the accumulation of pro-inflammatory, neurotoxic proteins and the potential to address unmet medical need across a number of neurodegenerative conditions and diseases.
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