Annovis Bio Announces Completion of Phase III Parkinson's Disease Treatment Enrollment at Record Pace

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Annovis Bio, Inc. announced that its PD phase III study of its lead compound buntanetap has reached full enrollment in a record nine months. Over 640 patients were screened and a total of 520 patients enrolled in record time with 67 sites. The study is expected to conclude in November with top-line assessment data available by the end of the year.

BERWYN, Pa., June 8, 2023 /PRNewswire/ -- 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 its PD phase III study of its lead compound buntanetap has reached full enrollment in a record nine months after it began. 

Since the first patient was dosed in late August 2022, over 640 patients were screened and a total of 520 patients enrolled in record time with 67 sites (43 in the United States and 24 in the European Union).  

The phase III trial is a randomized, double-blind, placebo-controlled trial investigating the efficacy, safety, and tolerability of buntanetap for early PD patients on top of their standard of care. Buntanetap (formerly known as Posiphen or ANVS401) attacks neurodegeneration by reducing multiple neurotoxic proteins, therefore improving synaptic transmission and axonal transport, the information highway of the nerve cell, which has been shown to be the cause of nerve cell degeneration and ultimately death. Unlike other PD drugs in development which attempt to remove only one toxic protein, buntanetap inhibits several toxic proteins before they can form, thereby preventing the formation of all the major neurotoxic proteins responsible for PD and AD.

By lowering levels of neurotoxic proteins, buntanetap improves axonal transport, lowers inflammation, fosters the health of nerve cells, and improves motor and cognitive dysfunction. 

The record enrollment and low drop-out rate are believed to be due to several factors: In phase I/II the drug showed improvements in body and motor function, it requires taking only one pill a day, and it is safe and well tolerated. The study is expected to conclude in November with top-line assessment data available by the end of the year.

"The Parkinson's community is extremely well-informed and connected," said Annovis' founder, president and CEO, Maria Maccecchini, Ph.D. ("Dr. Maria"). "When they learned of our innovative and patient-focused approach showing early therapeutic potential they wanted to be involved in making an impact." The ramifications of such drug therapy could be transformative for all neurodegenerative diseases, according to Dr. Maria.

About Annovis Bio, Inc.
Headquartered in Berwyn, Pa., 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 information about the company's clinical trials and patents, visit anovisbio.com, and follow the company on LinkedIn and Twitter.  

Forward-Looking Statements
This 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.

Communications Contacts:

Laura Feragen
Jacobson Strategic Health
laura@jacobsonstrategic.com 
267-262-4309

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SOURCE Annovis Bio

FAQ

What did Annovis Bio announce?

Annovis Bio announced that its PD phase III study of its lead compound buntanetap has reached full enrollment in a record nine months.

How many patients were enrolled in the study?

A total of 520 patients were enrolled in the study.

How long is the study expected to conclude?

The study is expected to conclude in November.

When will the top-line assessment data be available?

The top-line assessment data will be available by the end of the year.