BERWYN, PA — Annovis Bio, Inc. (NYSE: ANVS), a biopharmaceutical company focused on developing novel treatments for neurodegenerative diseases, recently announced a significant milestone in its clinical trial journey. The company’s Phase 2/3 trial of buntanetap, a drug candidate for moderate to mild Alzheimer’s Disease (AD), was given a positive safety review by the Independent Data and Safety Monitoring Board (DSMB). In a boost to Annovis’ research efforts, the DSMB recommended that the company continue with the trial as originally designed.
The DSMB based their endorsement on several key findings. Firstly, no drug-related Serious Adverse Events (SAEs) were reported. Secondly, each Adverse Event (AE) occurred at a rate of less than 5 percent. Lastly, the trial witnessed a very low dropout rate of 4.7 percent. These promising results affirm the safety profile of buntanetap, a vital factor in drug development and regulatory approval processes.
Commenting on the DSMB’s recommendation, Maria Maccecchini, Ph.D., CEO of Annovis, expressed optimism about the drug’s potential. “The findings from the DSMB are yet another positive affirmation for the direction we are taking in our research,” she said. “We believe they are an important step along the way to potentially treating Alzheimer’s Disease.”
The Phase 2/3 trial of buntanetap was initiated by Annovis in late March 2023. The DSMB safety evaluation was scheduled to take place once 90 patients had completed six weeks of treatment. By the time the DSMB convened on October 18, 2023, data from a total of 107 patients had been evaluated.
As of now, Annovis has recruited a total of 281 patients out of the planned 320 for the trial, with 76 patients having completed the study. This progress indicates a positive trend in patient recruitment and adherence, crucial aspects of a successful clinical trial.
In earlier Phase 2 trials for Alzheimer’s Disease, buntanetap was observed to improve cognition and speed of thinking. The drug, administered as a single daily pill, was generally well-tolerated by patients, highlighting its potential as a user-friendly treatment option.
The positive recommendation from the DSMB marks a significant stride for Annovis Bio in its quest to develop an effective treatment for Alzheimer’s Disease. It enhances the credibility of the company’s research efforts, making it an attractive proposition for investors looking for opportunities in the biopharmaceutical sector. As the trial progresses, all eyes will be on Annovis Bio and its promising drug candidate, buntanetap, offering hope for millions of Alzheimer’s Disease patients worldwide.
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