Phase 2/3 trial of Alzheimer’s therapy permitted to continue by monitoring board

Annovis Bio has been permitted by the Data and Safety Monitoring Board to continue its phase 2/3 trial of buntanetap, an oral protein inhibitor for moderate to mild Alzheimer’s disease, according to a company release.

The DSMB recommended that the trial can proceed as originally designed.

According to the release, feedback from the DSMB highlighted that the trial produced no drug-related serious adverse events, recorded no more than 5% of adverse events as a whole and had a dropout rate of 4.7%.

The clinical trial, which was initiated in March, is a randomized, double-blind, placebo-controlled study investigating safety, efficacy and tolerability of buntanetap as an adjunct to standard of care.

Safety evaluation by the DSMB was scheduled to occur when 90 patients completed at least 6 weeks of treatment, and by the time the board was convened Oct. 18, data from 107 patients was evaluated. The study has recruited 281 individuals out of the planned 320, and 76 enrollees have completed the study, the company said.

“The findings from the DSMB are yet another positive affirmation for the direction we are taking in our research,” Annovis CEO Maria Maccecchini, PhD, said in the release. “We believe they are an important step along the way to potentially treating Alzheimer’s disease.”