MALVERN, PA — Annovis Bio, Inc. (NYSE: ANVS), a Pennsylvania-based clinical-stage drug platform company, has announced the completion of the last patient visit in the phase II/III study of its lead candidate, buntanetap, a potential game-changer in the treatment of mild to moderate Alzheimer’s disease.
This marks a significant milestone for Annovis, which is developing novel therapies for neurodegenerative diseases. The study progressed as intended, with minimal dropout rates, according to Maria Maccecchini, Ph.D., Founder, President, and CEO of Annovis Bio.
“Our team is now fully focused on meticulously cleaning and analyzing the data, aiming to deliver results in a timely manner,” said Melissa Gaines, Senior Vice President, Clinical Operations at Annovis Bio.
The phase II/III trial involved a total of 327 patients out of the initial 353 enrolled, all of whom completed the study. It was a randomized, double-blind, placebo-controlled study investigating the efficacy, safety, and tolerability of buntanetap in patients with mild to moderate Alzheimer’s disease.
Patients were given one of three doses of buntanetap or a placebo alongside their standard care for 12 weeks. More than 700 patients were screened for the trial, which took place across 54 sites in the United States.
Buntanetap, previously known as Posiphen or ANVS401, is designed to fight neurodegeneration by inhibiting the formation of multiple neurotoxic proteins. These proteins have been shown to cause nerve cell degeneration and death, leading to conditions such as Alzheimer’s. By attacking these pathways, buntanetap could potentially reverse neurodegeneration in Alzheimer’s disease.
Annovis Bio is unique in that it is believed to be the only company developing a drug for both Alzheimer’s and Parkinson’s disease designed to inhibit more than one neurotoxic protein, aiming to restore axonal and synaptic activity. By improving brain function, the company’s goal is to treat memory loss and dementia associated with Alzheimer’s as well as body and brain dysfunction associated with Parkinson’s disease.
This landmark achievement puts Annovis Bio one step closer to realizing its mission of providing effective therapies for patients suffering from debilitating neurodegenerative diseases. The results of the phase II/III trial are eagerly awaited by the medical community and could signal a new era in the treatment of Alzheimer’s disease.
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