FDA Approves Finalized Study Protocol for Pivotal Phase 3 Alzheimer’s Disease Research

Annovis Bio, Inc.MALVERN, Pa., Jan. 07, 2025 (GLOBE NEWSWIR) — via IBN – Annovis Bio Inc. (NYSE: ANVS) (‘Annovis’ or the ‘Company’), a late-stage clinical drug platform company pioneering transformative therapies for neurodegenerative diseases such as Alzheimer’s disease (AD) and Parkinson’s disease (PD), today announced that the FDA has accepted an updated protocol for the pivotal Phase 3 AD study, which is slated to begin in January 2025. In October 2024, the FDA granted clearance for Annovis to proceed with the pivotal Phase 3 AD studies based on its Phase 2/3 data demonstrating cognitive improvement in early-stage AD patients. The original protocol design proposed two separate trials: a 6-month symptomatic study and an 18-month disease-modifying study. Under the revised protocol, these studies are now integrated into a single 6/18-month trial, which will include a 6-month data readout focused on symptomatic effects, followed by an additional 12-month assessment to evaluate the disease-modifying potential of buntanetap.

"This consolidated protocol will accelerate the development timeline while maintaining the scientific rigor necessary to advance buntanetap as a treatment for AD," said Maria Maccecchini, Ph.D., Founder, President, and CEO of Annovis. "With this design, we can leverage the 6-month symptomatic data to potentially support a New Drug Application (NDA) filing, all while continuing the same study seamlessly to assess long-term disease-modifying outcomes. We are excited to move forward with this approach, which brings us closer to delivering a novel treatment to patients in need."

About Annovis BioHeadquartered in Malvern, Pennsylvania, Annovis is dedicated to addressing neurodegeneration in diseases such as AD and PD. The company’s innovative approach targets multiple neurotoxic proteins, aiming to restore brain function and improve the quality of life for patients. For more information, visit www.annovisbio.com and follow us on LinkedIn, YouTube, and X.

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Forward-Looking StatementsThis press release contains ‘forward-looking’ statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements include, but are not limited to, the Company’s plans related to clinical trials. Forward-looking statements are based on current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Such risks and uncertainties include, but are not limited to, changes in regulatory approvals, market conditions, competition, and other factors affecting the business of Annovis Bio Inc.

While the FDA has granted clearance for the pivotal Phase 3 AD study, there can be no assurance that buntanetap will be approved or commercialized by Annovis. The information contained in this press release is as of its date of issuance and subject to change without notice. Neither the Company nor any other party makes any representations as to future events or results.

The updated protocol design reflects the Company’s commitment to advancing buntanetap as a potential game-changing treatment for AD. By combining two separate trials into one, Annovis aims to streamline the development process and potentially reduce the time required to bring buntanetap to market. This approach also allows the company to collect both symptomatic and disease-modifying outcome data in a single study, which could support faster regulatory approval and earlier patient access to this innovative therapy.

The success of Annovis Bio’s clinical trials will depend on several factors, including the efficacy and safety profile of buntanetap, as well as the ability to recruit and retain patients in the study. The company is currently working closely with its research teams across North America, Europe, and Asia to ensure that the trial proceeds smoothly and meets all regulatory requirements.

In addition to its focus on AD, Annovis Bio is also exploring innovative approaches for other neurodegenerative diseases, including Parkinson’s disease. The company’s pipeline includes several promising compounds that are currently in various stages of development, with a strong emphasis on early-stage trials to identify potential candidates for further advancement.

For more information about Annovis Bio and its commitment to revolutionizing the treatment of neurodegenerative diseases, please visit www.annovisbio.com or contact us at investor@annovisbio.com. Follow us on social media platforms such as LinkedIn, YouTube, and X for updates on our progress and new developments in the field of neuroscience.

In conclusion, Annovis Bio is well-positioned to make a significant impact in the fight against neurodegenerative diseases, thanks to its innovative approach and strong pipeline of experimental therapies. With this updated protocol design, the company continues to demonstrate its commitment to advancing buntanetap as a potential life-changing treatment for AD and paving the way for other innovative therapies in the future.

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