Company Provides Update on Clinical Trial Design of Upcoming Phase 3 Clinical Trials in Parkinson's Disease on March 20, 2022
Berwyn, Pennsylvania--(Newsfile Corp. - March 18, 2022) - Annovis Bio, Inc. (NYSE: ANVS) ("Annovis" or the "Company"), a clinical-stage drug platform company addressing neurodegenerative diseases, will present an update on the trial designs of the Company's upcoming Phase 3 trials evaluating Buntanetap in Parkinson's disease (PD) during the International Conference on Alzheimer's & Parkinson's Diseases (AD/PD™ 2022), hosted in-person in Barcelona, Spain, and virtually from March 15-20, 2022.
Buntanetap (previously known as ANVS401 or Posiphen) is an oral translational inhibitor of neurotoxic aggregating proteins (TINAPs) currently being developed for Alzheimer's disease (AD) and PD. In Phase 2a trials, Buntanetap was shown to be well-tolerated and safe, 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 met as Buntanetap treatment resulted in statistically significant improvement in motor function in PD patients and cognition in AD patients and in a reduction of the spinal fluid markers.
In January, the U.S. Food and Drug Administration (FDA) provided Annovis guidance for two Phase 3 clinical trials with Buntanetap in early and late PD. Maria L. Maccecchini, Ph.D., Founder, President, and CEO of Annovis, will present an update on the Phase 3 design in early PD patients during the talk "Positive clinical outcomes of Posiphen in two Phase 2a studies - Alzheimer's Disease and Parkinson's Disease" during the session "ABeta and other targeting therapies in AD", March 20, from 9:05-11:05 a.m. C.E.T. / 4:05-6:05 a.m. E.D.T. (Abstract SO394 / #308).
"We are encouraged and motivated by the positive results of the Phase2a study and the fruitful dialogue with the FDA," said Dr. Maccecchini. "Our Phase 3 trial and the broader program are aimed at advancing the development of Buntanetap towards our goal of transforming the lives of patients with neurodegenerative diseases."
The study plans to recruit 450 PD patients with Hoehn & Yahr 1, 2 and 3 and randomize them at 1:1:1 into placebo, 10mg or 20mg Buntanetap once daily - on top of their standard of care for six months. Primary endpoints will be assessed using MDS-UPDRS Part II and III, while secondary endpoints will be measured using total MDS-UPDRS and Participant Global Impression of Change. Additionally, exploratory endpoints will be evaluated through WAIS coding, plasma biomarkers and MMSE.
The presentation is available on the Events & Presentations section of the Annovis website.
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 2a clinical trial in AD and PD patients, Buntanetap was shown to be well-tolerated and safe, 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.
About Annovis Bio, Inc.
Headquartered in Berwyn, Pennsylvania, Annovis Bio, Inc. (Annovis) is a clinical-stage, drug platform company addressing neurodegeneration, such as Alzheimer's disease (AD), Parkinson's disease (PD), and other chronic neurodegenerative diseases, including Alzheimer's in Down Syndrome (AD-DS). We believe that we are the only company developing a drug for AD, PD, and AD-DS that inhibits more than one neurotoxic protein and, thereby, improves the information highway of the nerve cell, known as axonal transport. When this information flow is impaired, the nerve cell gets sick and dies. Annovis conducted two Phase 2 studies: one in AD patients and one in both AD and PD patients. In the AD/PD study Buntanetap showed improvement in memory loss and dementia associated with AD, as well as body and brain function in 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 Statements
Statements in this press release contain "forward-looking statements" that are subject to substantial risks and uncertainties. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "expect," "believe," "will," "may," "should," "estimate," "project," "outlook," "forecast" or other similar words, and include, without limitation, statements regarding the timing, effectiveness, and anticipated results of Buntanetap clinical trials. Forward-looking statements are based on Annovis Bio, Inc.'s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section titled "Risk Factors" in the Annual Report on Form 10-K for the year ended December 31, 2021, filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Annovis Bio, Inc. undertakes no duty to update such information except as required under applicable law.
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Media and Investor Contact:
Nic Johnson
Russo Partners, LLC
(303) 482-6405
nic.johnson@russopartnersllc.com
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