Annovis Bio Reports Positive Phase II/III Alzheimer's Early-Stage Results

Annovis Bio, Inc., a company dedicated to developing treatments for neurodegenerative diseases such as Alzheimer’s and Parkinson’s, has reported positive results from its Phase II/III study of the drug buntanetap in patients with mild to moderate Alzheimer’s disease. The study, involving 353 enrolled patients across 54 sites in the U.S., aimed to evaluate the efficacy, safety, and tolerability of buntanetap, an oral medication that targets the production of neurotoxic proteins implicated in neurodegeneration.

The research focused on patients with mild Alzheimer’s, defined by their Mini Mental State Examination (MMSE) scores and a specific plasma biomarker ratio. The primary outcome measures were changes in the Alzheimer’s Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog 11) and the Alzheimer’s Disease Cooperative Study Clinician’s Global Impression of Change (ADCS-CGIC). Results indicated a statistically significant improvement in ADAS-Cog 11 scores for patients receiving buntanetap at all three dose levels compared to placebo. Notably, the 30mg dose showed the most pronounced effect, with an improvement of 3.3 points compared to a 0.3 point improvement for placebo.

The study also revealed a strong correlation between treatment efficacy and the MMSE score at baseline, suggesting that buntanetap’s effects were more noticeable in patients with milder cognitive impairment. Furthermore, the number of responders, defined as those showing improvement, increased in a dose-dependent manner. The 30mg dose group showed a three-fold increase in responders compared to the placebo group.

Buntanetap was well-tolerated, with a safety profile consistent with previous trials and no serious adverse events attributed to the drug. Plasma biomarker analysis indicated a reduction in total Tau levels across all doses, aligning with earlier findings and supporting the drug’s proposed mechanism of action.

Annovis Bio plans to proceed with a pivotal Phase III trial in biomarker-positive early Alzheimer’s patients, following discussions with the FDA and presentations at the AAIC2024 conference. The company is encouraged by the symptomatic improvements and potential disease-modifying effects indicated by the reduction in Tau levels and aims to further validate these findings in future studies.

The development of buntanetap represents a novel approach to addressing neurodegeneration by inhibiting the formation of multiple neurotoxic proteins, which could potentially reverse the course of diseases like Alzheimer’s and Parkinson’s. Annovis Bio, based in Malvern, Pennsylvania, is committed to advancing brain function treatments for memory loss, dementia, and movement disorders associated with these diseases.