Annovis Bio, Inc. 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. 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.

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. 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 PD drugs in development which attempt to remove only one neurotoxic 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.