Annovis Bio Receives US FDA Nod to begin phase 3 studies of buntanetap

Annovis Bio Inc, based in Malvern, a company in the advanced stages of clinical drug development, revealed on October 10, 2024, the positive results of their meeting with the US Food and Drug Administration regarding transformative treatments for neurodegenerative diseases like Alzheimer's and Parkinson's.

The phase 3 program will examine buntanetap in early Alzheimer's disease patients through two clinical trials: a 6-month study to confirm symptomatic effects and an 18-month study to show potential disease-modifying effects. Although the Company intends to conduct both studies, a successfully run 6 month clinical trial may be enough to support filing for a new drug application, possibly within one year of starting the study.

Furthermore, the US FDA did not express any issues regarding the company's data on the safety of buntanetap, such as liver enzymes, drug interactions, dose selection, pharmacokinetics, and population pharmacokinetics. They verified that the development can continue using the new crystal form of buntanetap.

“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."