A recent regulatory approval from the U.S. Food and Drug Administration (FDA) has led to a substantial rise in the stock price of Annovis Bio, Inc. (NYSE: ANVS). As of the latest update, ANVS shares have increased by 6.72%, trading at $8.02. This upward trajectory is largely attributed to the announcement of a successful End-of-Phase 2 meeting with the FDA, which took place on October 10, 2024.
Upcoming Phase 3 Trials
During the End-of-Phase 2 meeting on October 10, 2024, Annovis secured approval to proceed with pivotal Phase 3 trials for its experimental therapy, buntanetap. With a clear developmental strategy established with the FDA, Annovis is now preparing to submit New Drug Applications (NDAs) that will address both immediate and long-term efficacy.
Comprehensive Study Design
The upcoming Phase 3 program will involve two distinct trials. The first will be a 6-month study aimed at confirming the symptomatic effects of buntanetap, while the second, an 18-month trial, is designed to demonstrate potential disease-modifying effects. Annovis intends to conduct both studies; however, a successful completion of the 6-month trial may suffice to support an NDA submission, which could be filed within a year of the study’s initiation.
Safety Data Assured
Furthermore, the FDA expressed no concerns regarding the safety data related to buntanetap, including factors such as liver enzymes, drug interactions, dose selection, and pharmacokinetics. The regulatory body also confirmed that development can proceed using the new crystal form of buntanetap.
Earlier this year, Annovis reported promising results from its Phase 2/3 clinical trial, which involved 353 patients and assessed the treatment’s efficacy in conjunction with standard care medications.
In anticipation of initiating the highly anticipated Phase 3 trials early next year, Annovis is committed to executing the upcoming clinical trials with the utmost precision. The company will maintain transparent communication with its stakeholders as it progresses towards its goal of delivering this potentially transformative treatment to patients.
