Monitoring board recommends Annovis Bio continue phase 3 trial of Parkinson’s drug

Annovis Bio announced it received a positive safety review from an independent Data and Safety Monitoring Board for its phase 3 trial of buntanetap, a drug for treatment of patients with early Parkinson’s disease.

According to a company release, the board recommended Annovis continue the trial as originally designed after a safety review found no drug-related serious adverse events, no single adverse event occurring in more than 2% of the enrolled study population, a low dropout rate of 6% and enrollment of 523 participants in 9 months, well ahead of expectations.

Annovis initiated the trial in late August 2022 at 67 sites across Europe and the United States, with the safety evaluation planned when 150 participants completed 2 months of treatment. Buntanetap, which inhibits multiple neurotoxic proteins responsible for PD and is administered as a single, once-daily pill, improved body and motor function in phase 2 trials, the company stated.

“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,” Maria Maccecchini, PhD, CEO of Annovis, said in the release.

As of June 9, 2023, the trial has completed enrollment and is expected to conclude in November, with top-line data available by the end of the year.