Annovis Bio Receives Positive Recommendation to Continue Phase 2/3 Trial of Buntanetap for Alzheimer’s Disease Patients From the Independent Data and Safety Monitoring Board (DSMB)

Rhea-AI Summary

Annovis Bio, Inc. (NYSE: ANVS) received a positive safety review from the Data and Safety Monitoring Board (DSMB) for its phase 2/3 trial of buntanetap, a drug candidate for Alzheimer's Disease (AD) patients. The DSMB recommended continuing the trial as planned. The feedback indicated no drug-related Serious Adverse Events (SAEs), a less than 5% dropout rate, and positive results in improving cognition and speed of thinking.

Positive

• The positive safety review from the DSMB is a significant milestone for Annovis Bio's buntanetap trial.
• The DSMB's recommendation to continue the trial as originally designed indicates confidence in the drug candidate's safety profile.
• The absence of drug-related Serious Adverse Events (SAEs) is a positive outcome for the trial.
• The low dropout rate of 4.7% demonstrates good patient adherence to the treatment.
• Previous phase 2 trials showed that buntanetap improved cognition and speed of thinking in Alzheimer's Disease patients.
• Buntanetap is administered as a single daily pill, making it convenient for patients.
• The positive feedback from the DSMB reinforces the potential of buntanetap in treating Alzheimer's Disease.

Negative

• None.

BERWYN, Pa.--(BUSINESS WIRE)-- Annovis Bio, Inc. (NYSE: ANVS), announces the positive safety review by the Data and Safety Monitoring Board (DSMB) for its phase 2/3 trial of buntanetap, a drug candidate for moderate to mild Alzheimer’s Disease (AD) patients. The DSMB recommended that Annovis Bio continue the trial as originally designed.

The feedback from the DSMB was:

1. no drug-related SAEs (Serious Adverse Events)
2. each AE (Adverse Event): less than 5 percent
3. very low dropout rate: 4.7 percent

“The findings from the DSMB are yet another positive affirmation for the direction we are taking in our research”, said Maria Maccecchini, Ph.D., CEO of Annovis. “We believe they are an important step along the way to potentially treating Alzheimer’s Disease.”

Annovis initiated the trial of buntanetap in late March 2023. The DSMB safety evaluation was set to occur when 90 patients completed 6 weeks of treatment. When the DSMB was convened on October 18, 2023, the data from a total of 107 patients was evaluated.

To date we have recruited a total of 281 patients out of the planned 320 patients; 76 patients have finished the study.

In our Alzheimer’s Disease phase 2 trials, buntanetap was observed to improve cognition and speed of thinking. It was easily administered as a single pill taken once daily and was generally well-tolerated.

About the Phase II/III Trial

This study is a phase 2/3, randomized, double-blind, placebo-controlled trial investigating the efficacy, safety, and tolerability of buntanetap for mild to moderate AD patients on top of their standard of care. Buntanetap (formerly known as Posiphen or ANVS401) attacks neurodegeneration by reducing multiple neurotoxic proteins, thereby improving synaptic transmission and axonal transport, which is the information highway of the nerve cell. Dysfunction of synaptic transmission and axonal transport has been shown to be the cause of nerve cell degeneration and ultimately death. Unlike other AD 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.

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 annovisbio.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 safety or 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20231030501881/en/

Investor Contact:

Maria Maccecchini

maccecchini@annovisbio.com

Source: Annovis Bio, Inc.

FAQ

What is the company behind the phase 2/3 trial of buntanetap for Alzheimer's Disease?

The company behind the trial is Annovis Bio, Inc. (NYSE: ANVS).

What was the recommendation from the Data and Safety Monitoring Board (DSMB)?

The DSMB recommended that Annovis Bio continue the trial as originally designed.

What were the key findings from the DSMB safety review?

The key findings were no drug-related Serious Adverse Events (SAEs), a less than 5% dropout rate, and positive cognitive improvements.

How many patients have been recruited for the trial?

A total of 281 patients have been recruited out of the planned 320 patients.

What were the results of previous phase 2 trials for buntanetap?

Previous phase 2 trials showed that buntanetap improved cognition and speed of thinking in Alzheimer's Disease patients.

How is buntanetap administered?

Buntanetap is administered as a single pill taken once daily.

What did the CEO of Annovis Bio say about the DSMB findings?

The CEO, Maria Maccecchini, stated that the DSMB findings were another positive affirmation for their research direction and a step towards potentially treating Alzheimer's Disease.