FDA Guides Annovis Bio For Two Phase 3 Buntanetap Trial In Parkinson's Disease

Annovis Bio Inc ANVS has completed a Type B meeting with the FDA regarding its planned Phase 3 studies of Buntanetap for the treatment of Parkinson's Disease (PD) as an offshoot of the Company's clinical program in Alzheimer's Disease (AD).

• Following the Company's submission of Phase 2 data and the chronic toxicology data in animals, the Company requested directions to further develop Buntanetap in PD. 
• The FDA guided initiating the Phase 3 clinical studies of Buntanetap for PD parallel with the AD program. 
• Related: EXCLUSIVE: Annovis Bio's Parkinson's Candidate Improves Speed, Motor Function Vs. Placebo.
• The agency detailed guidance on the specific endpoints, entry criteria, and further study parameters for two Phase 3 studies to support a broad indication for early and late PD.
• Additionally, the FDA provided guidance on updating the existing Investigational New Drug Application (IND) for AD based on the successful Phase 2 study result and in preparation for an End of Phase 2 meeting on the AD indication.
• Price Action: ANVS shares are down 4.12% at $13.25 during the market session on the last check Tuesday.