Phase 2/3 AD Study continues to make steady progress in patient recruitment
Company to hold R&D webcast on Thursday, April 20th 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:
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.
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.
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.
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