• Buntanetap improved cognition in pTau217-positive early AD patients
  • The drug reduced neurotoxic proteins as well as biomarkers of neuroinflammation and neurodegeneration
  • Buntanetap was safe and well-tolerated, including in ApoE4 carriers
  • Phase 2/3 findings support ongoing pivotal Phase 3 study in early AD, with 80% patients enrolled to date
     

MALVERN, Pa., April 28, 2026 (GLOBE NEWSWIRE) -- Annovis Bio, Inc. (NYSE:ANVS) ("Annovis" or the "Company"), a Phase 3 clinical-stage biotechnology company developing the investigational oral therapy, buntanetap, for neurodegenerative diseases such as Alzheimer's disease (AD) and Parkinson's disease (PD), today announced a new publication titled "Buntanetap treatment in mild to moderate Alzheimer's disease: phase 2/3 study" in a peer-reviewed journal Nature NPJ Dementia.

The Phase 2/3 study (NCT05686044) was a randomized, double-blinded, placebo-controlled trial evaluating three doses of buntanetap (7.5 mg, 15 mg, and 30 mg) over 12 weeks in 351 patients with mild to moderate AD. The study demonstrated that buntanetap was safe and well-tolerated across all disease stages and dose levels. Notably, safety was also assessed in ApoE4 carriers, the most genetically at-risk population for AD, with no increase in adverse events compared to non-carriers and to placebo. Given buntanetap's distinct mechanism of action, the drug was also well-tolerated when taken alongside approved symptomatic therapies, allowing patients to maintain their existing medication regimens without the need for discontinuation.

Study analyses revealed statistically significant, dose-dependent improvements in cognition, as measured by ADAS-Cog11, in pTau217 biomarker-positive patients with mild AD (MMSE 21–24). Moreover, at the 30 mg dose, buntanetap demonstrated a consistent treatment effect across all analyzed patient groups when stratified by age, body mass index, sex, ethnicity, ApoE4 carrier status, and concomitant medication use, with favorable effects versus placebo observed across each of these groups.

Biomarker analyses further revealed reductions in neurotoxic proteins TDP-43 and tau, in the markers of neuroinflammation, including IL-5, IL-6, S100A12, IFN-γ, and IGF1R, as well as in the marker of neurodegeneration, neurofilament light chain (NfL), pointing to potential disease-modifying activity. Importantly, the same trends were observed in plasma samples from patients with moderate AD, further supporting buntanetap's mechanism of action.

Buntanetap is currently being investigated in a pivotal Phase 3 clinical trial enrolling pTau217 biomarker-positive patients with early AD (MMSE 20–28) (NCT06709014). The trial is designed to replicate and extend the findings of the Phase 2/3 study, evaluating the efficacy of buntanetap at 6 and 18 months, measuring symptomatic and potential disease-modifying benefits, respectively. The study is nearing full enrollment, with 80% of patients already enrolled.