Core Viewpoint - Annovis Bio Inc. has initiated a pivotal Phase 3 study for its drug candidate, buntanetap, aimed at treating early Alzheimer's disease, marking a significant step towards market approval and addressing the needs of millions of patients [1][2]. Study Details - The Phase 3 trial is a randomized, placebo-controlled, double-blind study designed to assess the safety and efficacy of a daily dose of buntanetap over 18 months, with a 6-month symptomatic assessment followed by a 12-month evaluation of potential disease-modifying effects [3]. - The study protocol received FDA approval based on positive results from previous trials, which indicated significant cognitive improvement in a subgroup of early AD patients without safety concerns [3]. Financial Aspects - The company recently completed a public offering of 5,250,000 units, generating gross proceeds of $21 million, which will fund the initial 6-month portion of the study, with additional capital expected from warrant exercises for the 12-month phase [4]. Participant Enrollment - Annovis plans to enroll over 750 participants across approximately 100 sites in the United States, with the first two sites already recruiting patients [7]. Drug Mechanism - Buntanetap is an orally available molecule that targets neurodegeneration by inhibiting neurotoxic protein aggregation, improving axonal transport, synaptic transmission, and reducing neuroinflammation, potentially reversing neurodegeneration and enhancing 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