Annovis Bio falls after reporting data from Alzheimer study of buntanetap

Annovis Bio shares are lower in morning trading after the company, which is developing novel therapies for neurodegenerative diseases, such as Alzheimer’s, or AD, and Parkinson’s disease, or PD, announced the data from its Phase II/III Alzheimer study of buntanetap in mild to moderate AD patients. Based on these data, the company plans to conduct a pivotal Phase III trial in biomarker-positive early AD patients, Annovis reported. In this study, over 700 patients were screened, a total of 353 patients were enrolled, and 325 patients completed the study across 54 sites in the US. The study included mild to moderate AD patients whose Mini Mental State Examination scores at baseline ranged from 14 to 24. “Beyond safety, the trial assessed the changes in two co-primary endpoints: Alzheimer’s Disease Assessment Scale-Cognitive Subscale 11 and Alzheimer’s Disease Cooperative Study Clinician’s Global Impression of Change, which assess cognition and activities of daily living. The study monitored for safety and collected plasma to measure several biomarkers to assess the disease state, potential disease progression, and treatment effects. We observed a significantly higher improvement in ADAS-Cog 11 scores in each treatment dose relative to placebo for patients with mild AD. The analysis focused on biomarker-positive early AD patients found that ADAS-Cog 11 was highly statistically significant at all 3 dose levels and in the combined dose levels compared to placebo as well as to baseline. This objective measure of cognitive function confirms our findings from the two small Phase II studies that showed improvement in cognition in mild AD patients. The treatment response in the current study was not related to a patient’s age or sex,” the company stated. Melissa Gaines, SVP, Clinical Operations, and Cheng Fang, PhD, SVP, Research & Development, at Annovis Bio added: “This Phase II/III Alzheimer study builds and expands on the understanding we collected in the Phase II studies. Based on buntanetap’s unique mechanism of action, we believe it can give patients both symptomatic and disease-modifying benefits. It’s really exciting to see that this study confirmed what we have observed in the previous Phase II studies in both the improvement of patients’ cognition and the improvement of biomarkers. We are unaware of any double-blind, placebo-controlled studies demonstrating this level of improvement in the ADAS-Cog 11 after one and after three months. We are preparing the data to discuss with the FDA on how to proceed to show disease-modification, for presentation at AAIC2024 and for publication.” Near 10:30 am ET, Annovis shares are down $2.65, or 15%, to $15.36.