MALVERN, PA — Annovis Bio, Inc. (NYSE: ANVS this week announced a delay in the release of Phase III study data for its promising Parkinson’s Disease drug, buntanetap. The postponement is due to ongoing data cleaning efforts aimed at ensuring the accuracy and reliability of the study results.
The company had initially targeted a late January 2024 release for the data but is now working intensively to deliver the most accurate results. Maria Maccecchini, Ph.D., Founder, President, and CEO of Annovis, said, “We understand the anticipation surrounding the Phase III data announcement, and we recognize the potential frustration with the required extension. Our focus is on delivering trustworthy results, and we are working hard to provide them very soon.”
Annovis stated that it remains committed to maintaining open communication and will continue to provide timely updates on the Parkinson’s Phase III study results.
The Phase III trial is a randomized, double-blind, placebo-controlled study investigating the efficacy, safety, and tolerability of buntanetap in early-stage Parkinson’s Disease patients. Patients were treated with either buntanetap (10 mg or 20 mg dosage) or a placebo over six months. The study commenced in August 2022 and achieved full enrollment in just nine months. A total of 616 patients were screened, 523 randomized, and 471 completed across 67 sites in the United States and the European Union. The screen failure and drop-out rates were below projections at 15% and 9.9%, respectively.
Buntanetap, earlier known as Posiphen or ANVS401, is a novel approach to combating neurodegeneration by reducing multiple neurotoxic proteins. This action improves synaptic transmission and axonal transport, which are critical to the functioning of nerve cells. Buntanetap’s unique mechanism differentiates it from other Parkinson’s Disease drugs under development, which typically focus on removing a single toxic protein. By inhibiting several toxic proteins before they form, buntanetap prevents the formation of all the major neurotoxic proteins responsible for Parkinson’s and Alzheimer’s Diseases.
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