MALVERN, PA — Annovis Bio, Inc. (NYSE: ANVS) announced new clinical findings indicating that its lead candidate, buntanetap, reduces inflammation and improves cellular health in patients with Alzheimer’s disease, suggesting potential disease-modifying effects beyond symptomatic improvement.
The data, drawn from patient samples in the company’s Phase 2/3 Alzheimer’s study (NCT05686044), showed that buntanetap lowered key inflammatory biomarkers linked to neurodegeneration, including IL-5, IL-6, S100A12, IFN-γ, and IGF1R. These molecules are known to exacerbate amyloid-β accumulation and drive chronic neuroinflammation. The analysis also revealed decreased levels of neurofilament light chain (NFL), a protein associated with neuronal injury, indicating improved cellular integrity.
The biomarker improvements were consistent across all patients with positive plasma pTau217, a recognized indicator of Alzheimer’s pathology, and were observed in both mild and moderate cases of the disease.
“Alzheimer’s disease is multifactorial, and targeting just one of its causes has historically yielded limited therapeutic benefit,” said Maria Maccechini, Ph.D., President and CEO of Annovis. “What makes buntanetap truly promising is its ability to target multiple neurotoxic proteins simultaneously and interrupt the toxic cascade—something we have long believed was necessary for meaningful progress. These biomarker results validate our preclinical and earlier clinical findings and reinforce our confidence that we are on the right track.”
Previous data from the Phase 2/3 study showed that mild Alzheimer’s patients treated with buntanetap achieved significant cognitive improvement. The new biomarker evidence supports the drug’s potential to go beyond symptom management and alter the underlying disease process.
Buntanetap is currently being evaluated in a pivotal Phase 3 trial (NCT06709014) enrolling early Alzheimer’s patients across the United States. The trial features two readouts: a six-month analysis focused on symptomatic improvement and an 18-month assessment to evaluate disease modification.
According to the company, the biomarker analysis conducted after three months of treatment confirmed buntanetap’s engagement with its intended biological targets and pathways, reinforcing confidence in the ongoing Phase 3 study. Annovis noted that biomarker responses typically become more pronounced as the disease progresses, which may yield even stronger results at the 18-month analysis
Annovis Bio plans to present the full biomarker dataset at the upcoming Clinical Trials on Alzheimer’s Disease (CTAD) conference in San Diego, scheduled for December 1–4, 2025. Further presentation details will be released closer to the event.
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