Annovis Bio Reports Progress in Phase 3 Alzheimer's Trial with Promising Biomarker Data

Annovis Bio Inc. has achieved significant clinical and corporate milestones in the third quarter of 2025, with full activation of all 84 sites in its pivotal Phase 3 Alzheimer's study and steady patient enrollment across the United States. The late-stage clinical drug platform company, which focuses on developing therapies for neurodegenerative diseases including Alzheimer's and Parkinson's, reported promising biomarker data from its Phase 2/3 Alzheimer's trial showing strong reductions in inflammation and neurodegeneration, underscoring buntanetap's disease-modifying potential.

The company's clinical trial, registered as NCT06709014, represents a critical step toward potential regulatory submission. Recent corporate achievements include transferring all patents to the new crystal form of buntanetap with intellectual property protection extending through 2046, publishing supportive pharmacokinetic data, and appointing veteran finance executive Mark Guerin as Chief Financial Officer. These developments come as the company prepares for data readouts that could precede a New Drug Application submission.

Maria Maccecchini, Ph.D., president and CEO of Annovis Bio, emphasized the company's progress, stating that every element is now aligned as they move toward their data readouts. The biomarker data showing reductions in inflammation and neurodegeneration provides scientific validation for buntanetap's mechanism of action and its potential to address the underlying pathology of Alzheimer's disease rather than merely treating symptoms.

The company maintains its corporate website at https://www.annovisbio.com where additional information about their research and development programs is available. The full press release detailing these developments can be accessed through the company's newsroom at https://ibn.fm/ANVS, providing investors and stakeholders with comprehensive updates on the company's progress in neurodegenerative disease treatment development.

Annovis Bio's approach to treating neurodegenerative diseases represents a significant shift from current symptomatic treatments to potentially disease-modifying therapies. The reduction in inflammation and neurodegeneration markers observed in their Phase 2/3 trial suggests buntanetap may address multiple pathological pathways simultaneously, which could translate to improved patient outcomes and quality of life for those suffering from Alzheimer's disease and potentially other neurodegenerative conditions. The company's progress comes at a critical time when Alzheimer's disease affects millions worldwide, and current treatments primarily address symptoms rather than underlying disease processes. The biomarker data showing reductions in both inflammation and neurodegeneration is particularly significant because these are two key pathological features of Alzheimer's disease that contribute to cognitive decline. If buntanetap can demonstrate disease-modifying effects in the ongoing Phase 3 trial, it could represent a major advancement in Alzheimer's treatment, potentially slowing or halting disease progression rather than merely managing symptoms. The company's strategic positioning with intellectual property protection extending through 2046 provides long-term commercial potential if the drug receives regulatory approval. The appointment of an experienced finance executive as Chief Financial Officer suggests the company is preparing for the financial and operational demands of late-stage clinical development and potential commercialization. As the Phase 3 trial continues with all sites now activated, the medical community and patients await further data that could validate buntanetap's potential to change the treatment paradigm for Alzheimer's disease and possibly other neurodegenerative conditions.