Annovis Bio Provides Updated Schedule for Revealing Parkinson's Phase3 Trial Results

Annovis Bio, a company focused on developing treatments for neurodegenerative disorders, has reported a delay in the Phase III trial results for buntanetap, a drug intended for Parkinson's Disease. The data release, initially scheduled for January 2024, has been postponed to allow for meticulous data cleaning, which is crucial for ensuring the precision and reliability of the findings.

Maria Maccecchini, who holds the positions of Founder, President, and CEO at Annovis Bio, has acknowledged the eagerness of the scientific community and potential patients for the Phase III data. She emphasized that the company is committed to delivering results that are trustworthy and accurate, and that the data cleaning process is being handled with great care. At this stage, Annovis Bio is not privy to the data, and the statistical analysis has not yet commenced. Maccecchini reassured that despite the delay, the company is working diligently to provide the results as soon as possible.

The Phase III trial in question is a randomized, double-blind, placebo-controlled study that began in August 2022. It was designed to evaluate the efficacy, safety, and tolerability of buntanetap for early-stage Parkinson's Disease patients. The trial involved 471 patients who were treated with either buntanetap at dosages of 10 mg or 20 mg, or a placebo, over a period of six months. The trial was conducted across 67 sites, with 43 in the United States and 24 in the European Union. The screening process resulted in a 15% screen failure rate and a 9.9% dropout rate, both of which were lower than expected.

Buntanetap, previously known as Posiphen or ANVS401, is a unique drug candidate that targets neurodegeneration by reducing multiple neurotoxic proteins. This approach is aimed at improving synaptic transmission and axonal transport, which are critical for the functioning of nerve cells. The dysfunction of these processes has been linked to nerve cell degeneration and death. Unlike other Parkinson's drugs that focus on a single toxic protein, buntanetap is designed to inhibit several toxic proteins, preventing the formation of major neurotoxic proteins associated with both Parkinson's and Alzheimer's diseases.

Annovis Bio, Inc., headquartered in Malvern, Pennsylvania, is a clinical-stage company that is developing a drug platform to address various chronic neurodegenerative diseases, including Alzheimer's and Parkinson's. The company's approach is to develop a drug that can inhibit multiple neurotoxic proteins to restore axonal and synaptic activity, with the ultimate goal of treating memory loss and dementia associated with Alzheimer's, as well as the physical and cognitive impairments associated with Parkinson's.

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