Annovis has published peer-reviewed Phase 2/3 results for its oral candidate buntanetap in Nature NPJ Dementia, reporting cognitive improvements and biomarker changes in patients with mild to moderate Alzheimer’s disease.
The randomized, double-blind, placebo-controlled trial (NCT05686044) tested 7.5 mg, 15 mg and 30 mg doses over 12 weeks in 351 patients and found buntanetap to be safe and well tolerated across doses and disease stages, including in ApoE4 carriers.
Analyses showed statistically significant, dose-dependent improvements on ADAS-Cog11 in pTau217 biomarker-positive patients with mild disease (MMSE 21–24), with the 30 mg dose showing consistent effects across age, body mass index, sex, ethnicity, ApoE4 status and concomitant therapy use.
Biomarker assessments indicated reductions in neurotoxic proteins including TDP-43 and tau, decreases in markers of neuroinflammation such as IL-5, IL-6, S100A12, IFN-γ and IGF1R, and lower neurofilament light chain, which the company claims point to potential disease-modifying activity.
Annovis is advancing buntanetap in a pivotal Phase 3 trial enrolling pTau217-positive early alzheimer’s disease (MMSE 20–28) to evaluate 6- and 18-month outcomes, and reports the study is about 80% enrolled.
