Annovis Bio Announces Full Enrollment of Its Phase II/III Alzheimer’s Disease Trial, Exceeding Original Projections

Annovis Bio, Inc. (NYSE: ANVS), a clinical-stage drug platform company addressing neurodegenerative diseases such as Alzheimer’s (AD) and Parkinson’s disease (PD) and developing novel and transformative therapies, announced that AD phase II/III study of its lead compound buntanetap has exceeded full enrollment. 

Since the initiation of phase II/III study in March 2023, over 700 patients were screened and a total of 353 patients enrolled across 54 sites in the United States.

The phase II/III study is a randomized, double-blind, placebo-controlled trial investigating the efficacy, safety, and tolerability of buntanetap in patients with mild to moderate AD. This is a dose ranging study where patients receive either one of three doses of buntanetap (7.5mg, 15mg, or 30mg) or placebo on top of their standard of care for 12 weeks.

Buntanetap’s mechanism of action, favorable toxicology profile, and oral mode of administration distinguish it as superior to other AD drugs. Other drugs attempt to remove just one neurotoxic protein and, at best, have a minor effect. Buntanetap reduces levels of multiple neurotoxic proteins - Amyloid Beta, Tau, alpha Synuclein, and TDP43 – therefore improving synaptic transmission and axonal transport and reducing inflammation, which has been shown to be the cause of cell death. By attacking several pathways involved in neurodegeneration, buntanetap has the ability to reverse the destructive effects that Alzheimer’s Disease has on thinking and memory.

Annovis announced on October 12, 2023, the positive efficacy interim analysis and on October 30, 2023, the safety review by the Data and Safety Monitoring Board (DSMB). The efficacy and safety analysis reviewed by the DSMB recommended that Annovis continue the trial as originally designed. We expect the data from this study to read out by the end of March 2024.

“We are very pleased to share the news of the successful completion of enrollment for our phase II/III study of buntanetap in Alzheimer’s Disease,” said Annovis’ founder, president and CEO, Maria Maccecchini, Ph.D. "The number of enrolled patients exceeded our initial projections, revealing the Alzheimer’s community's strong endorsement of our mission to develop a treatment targeting multiple neurotoxic proteins. This not only proves their support but also underscores their willingness to contribute to advancing this important cause.”

About Annovis Bio, Inc.Headquartered in Berwyn, Pennsylvania, Annovis Bio, Inc. is a clinical-stage, drug platform company addressing neurodegeneration, such as Alzheimer’s Disease (AD), Parkinson’s Disease (PD), and other chronic neurodegenerative diseases. It is believed to be the only company developing a drug for both AD and PD designed to inhibit more than one neurotoxic protein to restore axonal and synaptic activity. By improving brain function, the company’s goal is to treat memory loss and dementia associated with AD as well as body and brain dysfunction associated with PD. For more information on Annovis Bio, please visit the Company's website www.annovisbio.com and follow us on LinkedIn and Twitter.

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. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The Company advises caution in reliance on forward-looking statements. Forward-looking statements include, without limitation, the Company's plans related to clinical trials. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results to differ materially from those implied by forward-looking statements, including regarding patient enrollment, the effectiveness of Buntanetap and the timing, effectiveness, and anticipated results of the Company's clinical trials evaluating the efficacy, safety and tolerability of buntanetap. See also additional risk factors set forth in the Company's periodic filings with the SEC, including, but not limited to, those risks and uncertainties listed in the section entitled "Risk Factors," in the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the SEC. All forward-looking statements in this press release are based on information available to the Company as of the date of this filing. The Company expressly disclaims any obligation to update or alter its forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.

Investor Contacts:Maria Maccecchini, [e-mail]