Annovis announced that new biomarker analyses from its Phase 2/3 Alzheimer’s disease (AD) trial (NCT05686044) showed that its investigational drug buntanetap reduced levels of several inflammatory markers. According to the company, reductions were observed in IL-5, IL-6, S100A12, IFN-γ and IGF1R versus placebo.
The company also reports that buntanetap decreased levels of neurofilament light chain (NFL), a marker released from damaged neurons, which it interprets as a sign of improved neuronal integrity. These changes were seen in all trial participants who tested positive for pTau217 in plasma, spanning mild to moderate disease stages, says the company.
Annovis notes that buntanetap had previously delivered clinical benefits in mild AD in the same study. It is now being evaluated in a pivotal Phase 3 trial in early AD (NCT06709014), which is designed with a 6-month symptomatic readout and an 18-month disease-modification readout.
The company said that the biomarker data were generated after just three months of treatment and add mechanistic support to its hypothesis that buntanetap may impact disease pathways beyond symptomatic relief. Full biomarker results will be presented at the Clinical Trials on Alzheimer’s Disease (CTAD) meeting in San Diego, December 1–4, 2025.
These findings, if confirmed, could reinforce buntanetap’s case as a therapy targeting underlying disease processes, though clinical outcomes and longer-term data from the Phase 3 readouts will be needed to validate the disease-modifying claim.
