Annovis Reveals Phase III Buntanetap Data for Parkinson's

Annovis Bio, Inc., a clinical-stage pharmaceutical company, has announced the completion of data cleaning for its Phase III trial of buntanetap, a drug designed for early-stage Parkinson’s disease (PD). The company, which is based in Malvern, Pennsylvania, had initially planned to announce data in the first quarter of 2024 but encountered an unexpected challenge during the data cleaning phase.

During the data unblinding process for the PD Phase III trial, the company found an unusually high number of plasma samples that showed no presence of buntanetap. The expected percentage of blank samples from the placebo group was 33%, but over 50% were found to be blank. This raised concerns about potential mix-ups in the distribution of medication, which could have rendered the study invalid.

In response to this issue, Annovis conducted a thorough investigation, examining every step of the process, including bottle content, distribution, labeling, and plasma sample distribution. All were found to be correct. The problem was eventually traced to the pharmacokinetic (PK) measurements, which are conducted using high-cost equipment and are regulated by stringent FDA rules. The team evaluating the PK had altered the method, which impacted the measurements. After repeating the PK analysis with the same samples, the expected 33% of blank samples for the placebo group was obtained.

This issue led to a two-month delay in the data announcement. However, the company has now rectified the situation and is prepared to evaluate the data for public and FDA review, with topline results expected to be reported in June.

Annovis Bio is a drug platform company that focuses on neurodegenerative diseases such as Alzheimer’s and Parkinson’s. The company is unique in that it is developing a drug that targets both diseases, aiming to inhibit multiple neurotoxic proteins to restore neuronal function. Their goal is to improve brain function and treat memory loss and dementia associated with Alzheimer’s, as well as the motor and cognitive symptoms of Parkinson’s.

The company's commitment to addressing the complexities of neurodegenerative diseases is evident in their approach to drug development. Despite the setback in the data cleaning process, Annovis has demonstrated resilience and a dedication to ensuring the integrity of their research. With the anticipated release of topline efficacy data in June, the company is poised to share important findings that could have significant implications for the treatment of Parkinson’s disease.