Malvern, Pennsylvania — August 14, 2026
Annovis Bio, Inc. announced that its pivotal Phase 3 Alzheimer’s disease trial of buntanetap is fully enrolled with 850 patients, exceeding the original enrollment target of 760 participants. The milestone represents a major clinical development step for the company as it advances its investigational oral therapy for Alzheimer’s disease (AD) toward an anticipated topline data readout in early 2027. The Phase 3 study is evaluating buntanetap in patients with early Alzheimer’s disease who are also positive for the plasma pTau217 biomarker, supporting the identification of participants with amyloid and tau pathology. The company said the study is designed to evaluate both symptomatic and potential disease-modifying effects, with cognition and functional ability serving as the co-primary endpoints. Annovis is also preparing an Alzheimer’s open-label extension study, expected to begin in October 2026, allowing eligible patients completing the pivotal study to continue receiving buntanetap.
Phase 3 Alzheimer’s Trial Reaches Full Enrollment
The Annovis Bio Phase 3 Alzheimer’s trial has enrolled 850 patients, surpassing the original target of 760 participants. The study includes patients with early AD and MMSE scores of 20–28, with plasma pTau217 positivity used to confirm underlying Alzheimer’s pathology. The trial evaluates cognition using ADAS-Cog13 and daily functioning through ADCS-iADL as co-primary endpoints, while volumetric MRI, pTau217 and additional biomarkers are being used to assess changes associated with disease pathology. The study is designed to examine buntanetap’s potential effects at both six months and 18 months. Annovis expects to complete the database lock for the six-month analysis during Q1 2027, with the topline symptomatic data expected in the same quarter. Disease-modifying data are expected approximately one year later. The company has also begun preparations for potential regulatory submission as it approaches these major clinical milestones.
Buntanetap Programs Expand in Alzheimer’s and Parkinson’s
Beyond the pivotal Alzheimer’s trial, Annovis is expanding long-term clinical evaluation of buntanetap through open-label extension programs. The planned Alzheimer’s OLE study, expected to initiate in October 2026, will allow eligible participants from the Phase 3 trial to continue buntanetap treatment after completing the 18-month treatment period. Participants previously receiving either buntanetap or placebo will be eligible to enter the extension, along with participants from earlier Annovis Alzheimer’s studies. In Parkinson’s disease, the company’s OLE study has enrolled 266 patients toward a target of approximately 500, with full enrollment projected for Q4 2026. The Parkinson’s program currently has 26 activated clinical sites across the United States and is designed to evaluate the safety and long-term efficacy of buntanetap over 36 months. The study incorporates NeuroRPM digital biomarker technology and skin biopsy assessments for alpha-synuclein pathology, providing additional measures for evaluating disease progression.
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Annovis Prepares for Key 2027 Clinical Milestones
The clinical progress comes as Annovis Bio strengthens its scientific and operational organization ahead of major data readouts. The company promoted Cheng Fang, Ph.D., to Chief Scientific Officer, where she will oversee clinical execution and scientific advancement of buntanetap. Annovis reported $18.7 million in cash and cash equivalents as of June 30, 2026, compared with $19.5 million at the end of 2025. Research and development expenses increased to $12.0 million for the second quarter, compared with $5.2 million during the same period in 2025, while general and administrative expenses increased to $2.4 million from $1.1 million. The company reported a net loss of $0.40 per basic and diluted share for the quarter. With the Alzheimer’s Phase 3 study fully enrolled, Parkinson’s OLE enrollment continuing and the Alzheimer’s OLE expected to begin later this year, buntanetap is entering a critical period of clinical development, with the first major Phase 3 Alzheimer’s data expected in early 2027.
Source:Annovis Bio, press relese
