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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 journalNature 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.
"The publication of these results in a peer-reviewed journal marks an important step in the scientific validation of buntanetap," said Cheng Fang, Ph.D., Senior Vice President, Research & Development. "The data reinforce what we have seen across multiple studies: buntanetap addresses the underlying pathology of AD with a safety profile that supports its use in a broad, genetically diverse patient population. The treatment effect we observed in biomarker-confirmed early AD patients provides strong scientific rationale as we advance our drug candidate through a pivotal Phase 3 study."
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.
About AnnovisHeadquartered in Malvern, Pennsylvania, Annovis Bio, Inc. (NYSE: ANVS) is a Phase 3 clinical-stage biotechnology company developing treatments for neurodegenerative diseases such as Alzheimer's disease (AD) and Parkinson's disease (PD). The Company's lead drug candidate, buntanetap (formerly posiphen), is an investigational once-daily oral therapy that inhibits the translation of multiple neurotoxic proteins, including APP and amyloid beta, tau, alpha-synuclein, and TDP-43, through a specific RNA-targeting mechanism of action. By addressing the underlying causes of neurodegeneration, Annovis aims to halt disease progression and improve cognitive and motor functions in patients. For more information, visitwww.annovisbio.comand follow us onLinkedIn,YouTube, andX.
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Forward-Looking StatementsThis press release contains forward-looking statements under the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended. Actual results may differ due to various risks and uncertainties, including those outlined in the Company’s SEC filings under “Risk Factors” in its Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. The Company undertakes no obligation to update forward-looking statements except as required by law.