Annovis Bio Receives Positive Recommendation To Continue Phase 2/3 Trial Of Buntanetap For Alzheimer's Disease Patients From The Independent Data And Safety Monitoring Board
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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:
- no drug-related SAEs (Serious Adverse Events)
- each AE (Adverse Event): less than 5 percent
- very low dropout rate: 4.7 percent
"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.
About the Phase II/III Trial
This study is a phase 2/3, randomized, double-blind, placebo-controlled trial investigating the efficacy, safety, and tolerability of buntanetap for mild to moderate AD patients on top of their standard of care. Buntanetap (formerly known as Posiphen or ANVS401) attacks neurodegeneration by reducing multiple neurotoxic proteins, thereby improving synaptic transmission and axonal transport, which is the information highway of the nerve cell. Dysfunction of synaptic transmission and axonal transport has been shown to be the cause of nerve cell degeneration and ultimately death. Unlike other AD drugs in development which attempt to remove only one toxic protein, buntanetap inhibits several toxic proteins before they can form, thereby preventing the formation of all the major neurotoxic proteins responsible for PD and AD.
