Core Insights - Annovis Bio Inc. has initiated a pivotal Phase 3 study for its drug candidate, buntanetap, targeting early Alzheimer's disease (AD) [1][2] - The study aims to evaluate both symptomatic and potential disease-modifying effects of buntanetap, following promising results from previous trials [2][3] Study Design and Objectives - The Phase 3 trial is a randomized, placebo-controlled, double-blind study lasting 18 months, with a 6-month assessment of symptomatic effects and a subsequent 12-month evaluation of disease-modifying effects [3] - Primary outcomes will include cognitive assessment using the Alzheimer's Disease Assessment Scale-Cognitive 13 (ADAS-Cog13) and functional ability using the Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living (ADCS-iADL) scale [6] Funding and Enrollment - The company completed a public offering of 5,250,000 units, raising gross proceeds of $21 million to fund the initial 6-month portion of the study [4] - Annovis plans to enroll over 750 participants across approximately 100 sites in the United States, with initial recruitment sites already operational [7] Drug Mechanism and Potential - Buntanetap is designed to inhibit neurotoxic protein aggregation, improving axonal transport and reducing neuroinflammation, which may reverse neurodegeneration and enhance patients' quality of life [8] Company Overview - Annovis Bio Inc. is focused on developing therapies for neurodegenerative diseases, including Alzheimer's and Parkinson's disease, and is headquartered in Malvern, Pennsylvania [9]
Annovis Announces First Patients Entered into Pivotal Phase 3 Study of Buntanetap for Early Alzheimer's Disease