Annovis Bio, Inc. announced the positive safety review by the Data and Safety Monitoring Board (DSMB) for its phase III trial of buntanetap, a drug for early Parkinson’s Disease (PD) patients. The DSMB recommended that Annovis Bio continue the trial as originally designed. The feedback from the DSMB was: no drug-related SAEs (Serious Adverse Events); each AE (Adverse Event): less than 2%; very low dropout rate: 6% and enrolled well ahead of expected timeline: 9 months to enroll 523 patients.

Annovis initiated the trial of buntanetap in late August 2022. Over 640 patients were screened and 523 were enrolled in just nine months, well ahead of typical enrollment speed. Patients were treated at a total of 67 sites (43 US and 24 EU).

The DSMB safety evaluation was set to occur when 150 patients completed two months of treatment. By that time, there were already a total of 414 patients enrolled worldwide, with only a 6% drop-out rate, which is significantly below expectations. No serious drug-related adverse events have been reported to date and no single adverse event occurring in more than 2% of the enrolled study population.

The planned enrollment has been reached and based on this DSMB endorsement, Annovis is excited to announce that topline results are expected by the end of 2023. In the Parkinson’s Disease phase II trials, buntanetap was shown to improve body and motor function. It is easily administered as a single pill taken once daily and is well-tolerated.

These factors contributed to the accelerated enrollment and low drop-out rate. As of June 9, 2023, the trial has completed enrollment and is expected to conclude in November, with top-line data available by the end of the year. 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.

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 toxic 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.