A Data and Safety Monitoring Board (DSMB) recommended that Annovis Bio (NYSE:ANVS) continue its Phase 3 trial as originally designed of buntanetap, a drug for early Parkinson’s disease (PD) patients.
The DSMB decision reflected no drug-related serious adverse events; each adverse event: less than 2%; a very low dropout rate of 6%; and enrollment was well ahead of the expected timeline of nine months to enroll 523 patients.
Patients were treated at a total of 67 sites, of which 43 are in the U.S. and 24 in the 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.
Annovis is expected to announce topline results by the end of 2023.
In the PD Phase 2 trials, buntanetap was shown to improve body and motor function. It is administered as a single pill taken once daily and is well-tolerated. These factors contributed to the accelerated enrollment and low drop-out rate.
