Annovis Bio Announces Publication of Phase 2a Clinical Data in The Journal of Prevention of Alzheimer’s Disease
BERWYN, Pa., October 11, 2022 /PRNewswire/ — Annovis Bio, Inc. (NYSE: ANVS) (“Annovis” or the “Company”), a late-stage clinical drug platform company treating neurodegenerative diseases, today announced the publication data from the phase 2a clinical study in The Journal of Alzheimer’s Disease Prevention.
The published study, titled ‘Buntanetap, a new translational inhibitor of several neurotoxic proteins, shows promise and safety in Alzheimer’s and Parkinson’s patients‘, evaluated the safety, pharmacokinetics, biomarkers and efficacy of buntanetap in the treatment of patients with early-stage Alzheimer’s disease (AD) and Parkinson’s disease (PD). The study demonstrated that buntanetap was well tolerated, safe, and significantly improved cognition in patients with AD and motor function in patients with PD.
“Given the short duration of our Phase 2a clinical trial, we are pleased to see that patients treated with buntanetap showed statistically significant improvement in cognition and function,” said Maria L. Maccecchini, Ph. D., Founder, President and CEO. from Anvis Bio. “We believe that the effects on cognition and motor function after such a short course of treatment are due to the ability of buntanetap to restore neuronal function through improved axonal integrity, synaptic transmission and reduction of inflammation.”
Cheng Fang, Ph.D., Senior Vice President of Research and Development at Annovis Bio, added, “These fast-acting effects suggest that buntanetap may work as a symptomatic medication to give patients rapid relief from their neurological symptoms. Based on animal studies, we also believe that buntanetap may work as a disease-modifying drug in patients with AD and PD, as it will continue to reduce levels of neurotoxic aggregation proteins and preserve integrity neuronal. We are testing this hypothesis further in our late-stage clinical trials with larger patient populations and longer treatment times.”
Annovis began dosing patients in the company’s Phase 3 clinical trial evaluating buntanetap in early PD. The Phase 3 trial is a randomized, double-blind, placebo-controlled trial investigating the efficacy, safety, and tolerability of buntanetap. The trial will enroll a total of 450 patients with early-stage Parkinson’s disease who will be treated with 10 mg of buntanetap, 20 mg of buntanetap or placebo, in addition to their standard treatment for six months.
In early October, the US Food and Drug Administration authorized a Phase 2/3 clinical study of buntanetap in moderate AD. The Phase 2/3 study is a randomized, double-blind, placebo-controlled trial investigating the efficacy, safety, and tolerability of buntanetap in patients with moderate AD. The trial will enroll a total of 320 AD patients who will be treated with 7.5mg buntanetap, 15mg buntanetap, 30mg buntanetap or placebo, in addition to their standard therapy for three months.
Buntanetap (formerly known as ANVS401 or Posiphen) is an oral translation inhibitor of neurotoxic aggregating proteins (TINAPs), whose 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 patients with AD and PD, buntanetap was shown to be well tolerated and safe, and its pharmacokinetics were consistent with levels previously measured in humans, satisfying both primary and secondary endpoints. Additionally, exploratory endpoints were also met, as buntanetap treatment resulted in statistically significant improvement in motor function in patients with PD and cognition in patients with AD. Currently, buntanetap is in a Phase 3 study in early PD and will enter a Phase 2/3 study in patients with AD later this year.
About Anvis Bio, Inc.
Based in Berwyn, Pennsylvania, Annovis Bio, Inc. is a clinical-stage pharmaceutical platform company developing transformative therapies that treat neurodegenerative disorders such as Alzheimer’s disease (AD), Parkinson’s disease (PD ) and other chronic and acute neurodegenerative diseases. The Company believes it is the only company to develop a drug that inhibits more than one neurotoxic protein, improves the nerve cell’s information highway, known as axonal transport, reduces inflammation and protects nerve cells against death in chronic and acute neurodegeneration. Annovis has conducted two phase 2 studies: one in patients with Alzheimer’s disease and one in patients with Alzheimer’s disease and Parkinson’s disease. In the AD/PD study, buntanetap showed improvements in cognition and memory in AD as well as body and brain function in patients with Parkinson’s disease.
The statements in this press release contain “forward-looking statements” that are subject to substantial risks and uncertainties. Forward-looking statements in this press release can 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, but are not limited to, statements regarding the timing, effectiveness, and expected results of clinical trials of buntanetap. 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. In addition, certain forward-looking statements are based on assumptions about future events which may not prove to be accurate. These and other risks and uncertainties are described in more detail in the section titled “Risk Factors” of the Annual Report on Form 10-K for the fiscal year ended December 31, 2021, filed with the Securities and Exchange. Commission. The forward-looking statements contained in this announcement are made as of this date, and Annovis Bio, Inc. assumes no obligation to update such information except as required by applicable law.
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