Annovis Bio Gets US FDA Approval to Start Pivotal Phase 3 Studies on Buntanetap

Annovis Bio gets US FDA clearance to begin pivotal phase 3 studies of buntanetap, paving the way for NDAs filing

Overview

Malvern headquartered Annovis Bio Inc, a late-stage clinical drug platform company developing transformative therapies for neurodegenerative disorders such as Alzheimer’s disease  and Parkinson’s disease, announced the successful outcome of the end-of-phase 2 meeting with the US Food and Drug Administration on October 10, 2024. During the meeting, the US FDA granted clearance to proceed with pivotal phase 3 studies, based on the company’s phase 2/3 clinical data showing symptomatic improvement in early Alzheimer’s disease patients. Annovis and the US FDA have now aligned on a development path for buntanetap towards the filing of new drug applications (NDAs), one for short-term and one for long-term efficacy.

Objective of Phase 3 Program

• The phase 3 program will investigate buntanetap in patients with early Alzheimer’s disease and will consist of two clinical trials: a 6 months study aimed at confirming buntanetap’s symptomatic effects and an 18 months study designed to demonstrate potential disease-modifying effects. 
• While the Company plans to run both studies, the completion of a well-designed and well-executed 6 months clinical trial may be sufficient to support new drug application filing, potentially within one year of the study’s initiation.

Safety of Buntanetap Use

Additionally, the US FDA raised no concerns about the company’s data on buntanetap’s safety, including liver enzymes, drug interactions, dose selection, pharmacokinetics, and population pharmacokinetics and confirmed that development can proceed using the new crystal form of buntanetap.

Words from the CEO: Annovis Bio

• We are now ready to move into the highly anticipated phase 3 stage,” said Maria Maccecchini, founder, president, and CEO of Annovis Bio. 
• Our priority is to bring the treatment to patients as early as possible, and we are committed to ensuring the next clinical trial is executed at the highest standards to attain an expedited NDA submission. Our team is already preparing for trial initiation early next year and will continue to keep you updated as we advance towards our goal.

About the company: Annovis Bio Inc.

• Annovis Bio Inc. is dedicated to addressing neurodegeneration in diseases such as Alzheimer’s disease and Parkinson’s disease. 
• The company’s innovative approach targets multiple neurotoxic proteins, aiming to restore brain function and improve the quality of life for patients.