MALVERN, PA — Annovis Bio, Inc. (NYSE: ANVS) recently published results from a Phase 2/3 clinical trial evaluating its investigational drug buntanetap in patients with mild to moderate Alzheimer’s disease, reporting cognitive improvements in certain biomarker-positive patients and continued advancement of a late-stage study.
The randomized, double-blind, placebo-controlled trial enrolled 351 patients who received buntanetap at doses of 7.5 mg, 15 mg, or 30 mg over 12 weeks.
The study found statistically significant, dose-dependent improvements in cognition, measured by ADAS-Cog11, in patients with mild Alzheimer’s disease who tested positive for the pTau217 biomarker.
At the 30 mg dose, the drug showed consistent effects across subgroups defined by age, body mass index, sex, ethnicity, ApoE4 carrier status, and use of other medications.
The company reported that buntanetap reduced levels of neurotoxic proteins, including TDP-43 and tau, as well as biomarkers associated with neuroinflammation and neurodegeneration, including IL-5, IL-6, S100A12, IFN-γ, IGF1R, and neurofilament light chain.
Safety data showed the drug was well tolerated across all dose levels and disease stages, including among ApoE4 carriers, a group at higher genetic risk for Alzheimer’s disease. No increase in adverse events was observed compared with placebo, and patients were able to continue standard symptomatic treatments during the trial.
The findings were published in the peer-reviewed journal Nature NPJ Dementia.
Cheng Fang, senior vice president of research and development, said the results support continued development of buntanetap, citing observed treatment effects in biomarker-confirmed early Alzheimer’s patients.
Buntanetap is being evaluated in an ongoing Phase 3 trial enrolling patients with early Alzheimer’s disease who are positive for the pTau217 biomarker. The study is designed to assess efficacy at six and 18 months and is approximately 80% enrolled.
Annovis Bio is developing oral therapies targeting neurodegenerative diseases, including Alzheimer’s and Parkinson’s.
Support the local news that supports Chester County. MyChesCo delivers reliable, fact-based reporting and essential community resources—free for everyone. If you value that, click here to become a patron today.