ANNOVIS BIO ANNOUNCES UPDATE ON RECRUITMENT INTO ITS PHASE 2/3 ALZHEIMER'S STUDY AND UPCOMING R&D WEBCAST

Rhea-AI Summary

Annovis Bio, Inc. (NYSE: ANVS) announced steady progress in recruiting patients for its Phase 2/3 study of buntanetap, targeting moderate Alzheimer's disease. Currently, 27 sites have been activated, screening 38 patients, with 13 randomized to receive either buntanetap or placebo. The trial aims to involve 320 patients, assessing the drug's efficacy, safety, and tolerability over three months at various doses. Past Phase 2 results showed significant cognitive improvement in patients treated with buntanetap. The company will hold an R&D webcast on April 20, 2023, to discuss its clinical programs further.

Positive

• Steady recruitment progress in Phase 2/3 study for Alzheimer's treatment.
• Previous Phase 2 results indicated a 30% improvement in cognitive function with buntanetap.

Negative

• None.

Phase 2/3 AD Study continues to make steady progress in patient recruitment

Company to hold R&D webcast on Thursday, April 20^th to review ongoing clinical programs in Alzheimer's disease and Parkinson's disease

BERWYN, Pa., April 19, 2023 /PRNewswire/ -- Annovis Bio, Inc. (NYSE: ANVS) ("Annovis" or the "Company"), a clinical-stage drug platform company addressing neurodegenerative diseases, today announced that patient recruitment for the Company's Phase 2/3 study of buntanetap for the treatment of moderate Alzheimer's disease (AD) remains consistent with its planned development program.

To date, a total of 27 sites have now been activated and 38 patients have been screened in the Phase 2/3 study. In addition, 13 patients have been randomized to receive either one of three doses of buntanetap or placebo.  

Annovis will hold an R&D webcast on Thursday, April 20, 2023 at 4 PM to review its late-stage clinical programs in AD and Parkinson's disease (PD). Details on the webcast are provide below:

Webcast details:

Date: April 20, 2023, 4PM
Participant Toll-Free Dial-In Number: 1 (888) 210-3702
Participant Toll Dial-In Number: 1 (646) 960-0191
Conference ID: 7935665
Webcast Link:  https://events.q4inc.com/attendee/892955864 

Maria L. Maccecchini, Ph.D., Founder, President, and CEO of Annovis, commented: "We are very pleased to announce the ramp up of our Phase 2/3 study of buntanetap for the treatment of AD. AD is associated with chronic, low-level neuro-inflammation, which is likely due to the overexpression of neurotoxic proteins such as amyloid beta, tau, αSynuclein, and TDP43. By targeting the complex of the iron response element 1 (IRE1) with the mRNAs coding for these neurotoxic proteins, buntanetap blocks their translation and helps reduce the pro-inflammatory conditions seen in AD. In our upcoming R&D webcast, we look forward to discussing our Phase 2/3 trial as well as an overview of the planned development program for AD and PD."    

The Phase 2/3 study is a randomized, double-blind, placebo-controlled trial investigating the efficacy, safety, and tolerability of buntanetap in moderate AD patients. The trial is expected to enroll a total of 320 AD patients into three active arms to be treated with 7.5mg buntanetap, 15mg buntanetap, 30mg buntanetap or a placebo, on top of their standard of care, for three months. In October 2022, the Company received permission from the FDA to proceed with the Phase 2/3 clinical study. 

In July 2021, the Company announced positive Phase 2 results demonstrating that treatment with buntanetap resulted in statistically significant improvements in cognitive function in patients with AD.  Specifically, patients treated with buntanetap showed a 4.7-point or 30% improvement while the placebo group showed a 1.1-point improvement in ADAS-Cog11.² Additionally, the WAIS coding test, which measures speed in movement and thinking, found that treated AD patients had a 6.6-point improvement in coding after buntanetap treatment.

Additional information about the Phase 2/3 study is available here.

About Buntanetap
Buntanetap (previously known as ANVS401 or Posiphen) is an oral translational inhibitor of neurotoxic aggregating proteins (TINAPs), which mode of action leads to a lower level of neurotoxic proteins and consequently less toxicity in the brain. In a Phase 1/2 clinical trial in AD and PD patients, buntanetap was shown to be well-tolerated and its pharmacokinetics were found to be in line with levels measured earlier in humans, meeting both the primary and secondary endpoints. Additionally, exploratory endpoints were also met, as treatment with buntanetap resulted in statistically significant improvement in motor function in PD patients and cognition in AD patients. Presently buntanetap is being studied in a Phase 3 study in early PD patients and in a Phase 2/3 study in mild to moderate AD patients.

About Annovis Bio, Inc.
Headquartered in Berwyn, Pennsylvania, Annovis Bio, Inc. (Annovis) is a clinical-stage, drug platform company addressing neurodegeneration, such AD, PD, and other chronic neurodegenerative diseases. We believe that we are the only company developing a drug for AD and PD that is designed to inhibit more than one neurotoxic protein, and has a mechanism of action designed to restore axonal and synaptic activity. By improving brain function, our goal is to treat memory loss and dementia associated with AD as well as body and brain function associated with PD.  Annovis conducted two Phase 1/2 studies: one in AD patients and one in both AD and PD patients. In the AD/PD study buntanetap showed improvements in cognition in AD as well as body and function in PD patients.

For more information on Annovis Bio, please visit the Company's website www.annovisbio.com and follow us 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.

Media Contact:
Nic Johnson
Russo Partners, LLC
(303) 482-6405
nic.johnson@russopartnersllc.com

Investors Contacts:
Chris Calabrese
+1 (917) 680-5608
ccalabrese@lifesciadvisors.com
LifeSci Advisors, LLC

Kevin Gardner
+1 (617) 283-2856
kgardner@lifesciadvisors.com
LifeSci Advisors, LLC

 

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SOURCE Annovis Bio

FAQ

What is the objective of Annovis Bio's Phase 2/3 study for Alzheimer's disease?

The Phase 2/3 study aims to evaluate the efficacy, safety, and tolerability of buntanetap in patients with moderate Alzheimer's disease.

How many patients are involved in Annovis Bio's Phase 2/3 Alzheimer's study?

The trial aims to enroll a total of 320 patients.

When is Annovis Bio's R&D webcast scheduled?

The R&D webcast is scheduled for April 20, 2023, at 4 PM.

What were the results from the previous Phase 2 study of buntanetap?

The previous Phase 2 study showed a 30% improvement in cognitive function for patients treated with buntanetap compared to the placebo group.

What is the treatment approach of buntanetap in the study?

Buntanetap targets neurotoxic proteins associated with Alzheimer's disease, aiming to reduce chronic neuro-inflammation.