Annovis Bio Alzheimer’s Study “Powered For Potential Success”
Annovis Bio (Nasdaq: ANVS) has announced its Phase 2/3 study evaluating a treatment for Alzheimer’s disease (AD) is sufficiently powered to continue as originally planned without the addition of patients, according to an independent statistical group review. The study is designed to enroll a total of 320 mild to moderate AD patients.
To date, 230 patients have been enrolled and 62 have finished the study. Full enrollment is anticipated in November and completion of treatment is expected in February 2024. Annovis expects to release topline data in March 2024.
Maria L. Maccecchini, Ph.D., Founder, President, and CEO of Annovis, said, “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.”
Highlights
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.
Annovis stated: As we move forward with our advanced, clinical-stage AD and PD programs, we hope to demonstrate buntanetap’s unique ability to inhibit the accumulation of pro-inflammatory, neurotoxic proteins and potential to address unmet medical need across a number of neurodegenerative conditions and diseases.
Buntanetap is an investigational, oral translational inhibitor of neurotoxic aggregating proteins (TINAPs), thought to lead to a lower level of neurotoxic proteins and consequently less toxicity in the brain.
In a Phase 2a clinical trial, buntanetap was shown to be generally well-tolerated, and met the study’s primary and secondary endpoints.
About Annovis Bio
Headquartered in Berwyn, Pennsylvania, Annovis Bio, Inc. (Annovis) is a clinical-stage, drug platform company addressing neurodegeneration, such as Alzheimer’s disease (AD), Parkinson’s disease (PD), and other chronic neurodegenerative diseases. We believe that we are the only company developing a drug for AD and PD that inhibits more than one neurotoxic protein and, thereby, improves the information highway of the nerve cell, known as axonal transport. When this information flow is impaired, the nerve cell gets sick and dies. Annovis conducted two Phase 2 studies: one in AD patients and one in both AD and PD patients. In the AD/PD study buntanetap showed improvements in cognition and memory in AD as well as body and brain function in PD patients.
