Annovis Bio Receives Excellent Safety Rating and Positive Recommendation to Cont Press Release

The drug is proving to be safe and well-tolerated

Annovis Bio, Inc. ANVS, announces the positive safety review by the Data and Safety Monitoring Board (DSMB) for its phase III trial of buntanetap, a drug for early Parkinson’s Disease (PD) patients. The DSMB recommended that Annovis Bio continue the trial as originally designed.

The feedback from the DSMB was:

1. no drug-related SAEs (Serious Adverse Events)
2. each AE (Adverse Event): less than 2 percent
3. very low dropout rate: 6 percent
4. enrolled well ahead of expected timeline: 9 months to enroll 523 patients.

“It’s exciting that our drug is proving to be safe, well-tolerated, is easily administered as a once-a-day pill and has therapeutic potential, all of which have important implications for the transformative treatment of all neurodegenerative diseases,” said Maria Maccecchini, Ph.D., CEO of Annovis.

Annovis initiated the trial of buntanetap in late August 2022. Over 640 patients were screened and 523 were enrolled in just nine months, well ahead of typical enrollment speed. Patients were treated at a total of 67 sites (43 US and 24 EU). The DSMB safety evaluation was set to occur when 150 patients completed two months of treatment. By that time, there were already a total of 414 patients enrolled worldwide, with only a six percent drop-out rate, which is significantly below expectations. No serious drug-related adverse events have been reported to date and no single adverse event occurring in more than two percent of the enrolled study population.

The planned enrollment has been reached and based on this DSMB endorsement, Annovis is excited to announce that topline results are expected by the end of 2023.

In the Parkinson’s Disease phase II trials, buntanetap was shown to improve body and motor function. It is easily administered as a single pill taken once daily and is well-tolerated. These factors contributed to the accelerated enrollment and low drop-out rate.

As of June 9, 2023,…

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