Annovis Bio, Inc. (NYSE: ANVS), a clinical-stage drug platform company developing novel therapies for neurodegenerative diseases, has announced a postponement in the Phase III study data release for buntanetap in Parkinson’s Disease. This adjustment is due to ongoing data cleaning efforts to ensure the accuracy and reliability of the study results.
“We acknowledge the ongoing anticipation for the Phase III data announcement initially set for the end of January 2024. However, the delivery of the cleaned data is now delayed as we work to provide the most accurate results by ensuring the process is conducted diligently and thoroughly," said Maria Maccecchini, Ph.D., Founder, President, and CEO of Annovis. "During this period, the Company remains blinded to the data, and the statistical analysis is yet to be performed. We understand your potential frustration with the required extension, and we want to stress that our focus is on delivering results that are trustworthy. We are working hard to provide them to you very soon."
The Company is dedicated to maintaining open communication and will continue to provide updates for Parkinson’s Phase III study results in a timely and informative manner.
About the Phase III Trial
This study is a Phase III, randomized, double-blind, placebo-controlled trial investigating the efficacy, safety, and tolerability of buntanetap for early PD patients on top of their standard of care. Patients were treated with buntanetap (10 mg or 20 mg) or placebo for 6 months. The study was initiated in August 2022 with a record pace of full enrollment in just nine months and a total of 616 screened, 523 randomized and 471 completed patients across 67 sites (43 in the United States and 24 in the European Union). Screen failure (15%) and drop out (9.9%) rates were below projections.
https://www.biospace.com/article/releases/annovis-bio-refines-timeline-for-parkinson-s-phase-iii-study-data-announcement/
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