Annovis Bio, Inc. (NYSE: ANVS), announces the positive safety review by the Data and Safety Monitoring Board (DSMB) for its phase 2/3 trial of buntanetap, a drug candidate for moderate to mild Alzheimer’s Disease (AD) patients. The DSMB recommended that Annovis Bio continue the trial as originally designed.
The feedback from the DSMB was:
“The findings from the DSMB are yet another positive affirmation for the direction we are taking in our research”, said Maria Maccecchini, Ph.D., CEO of Annovis. “We believe they are an important step along the way to potentially treating Alzheimer’s Disease.”
Annovis initiated the trial of buntanetap in late March 2023. The DSMB safety evaluation was set to occur when 90 patients completed 6 weeks of treatment. When the DSMB was convened on October 18, 2023, the data from a total of 107 patients was evaluated.
To date we have recruited a total of 281 patients out of the planned 320 patients; 76 patients have finished the study.
In our Alzheimer’s Disease phase 2 trials, buntanetap was observed to improve cognition and speed of thinking. It was easily administered as a single pill taken once daily and was generally well-tolerated.
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