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Berwyn, Pennsylvania--(Newsfile Corp. - April 11, 2022) - Annovis Bio, Inc. (NYSE: ANVS) ("Annovis" or the "Company"), a clinical-stage drug platform company addressing neurodegenerative diseases, is pleased to participate in World Parkinson's Day to promote greater awareness of how Parkinson's disease affects those living with the progressive disease and support research efforts to develop disease-modifying treatment options.
An estimated one million people in the U.S. and more than ten million people worldwide live with Parkinson's, making it the second-most common neurodegenerative disease after Alzheimer's and the 14th-leading cause of death in the United States.
High levels of neurotoxic proteins, caused by chronic and acute brain insults, lead to the onset of a wide range of neurodegenerative disease; in Parkinson's these proteins affect predominately neurons involved in motor control, i.e., movement, or dopamine-producing, in a specific area of the brain called the substantia nigra. In this region, neurotoxic proteins impair axonal transport and cause a toxic cascade leading to slower synaptic transmission, inflammation, death of dopaminergic neurons and, ultimately, loss of motor function.
Symptoms vary, but can include tremors, difficulty with balance, swallowing, chewing, and speaking, and cognitive impairment. No matter the symptoms, a diagnosis of Parkinson's is life-changing for patients and their family members. As of today, there are many medications for treating symptoms, however none that change the course of the disease.
"The incidence and prevalence of Parkinson's disease is extremely concerning. With an aging population and no disease-modifying treatments available, the urgency to develop a solution cannot be underestimated. This is why Annovis supports our community's common efforts to foster innovation that will produce the greatest benefit to patients," commented Maria L. Maccecchini, Ph.D., Founder, President, and CEO of Annovis. "We believe in our innovative approach of inhibiting the buildup of neurotoxic proteins and improving the information highway of the nerve cell. Our team remains committed to transforming the lives of patients with Parkinson's as we further advance Buntanetap in Phase 3 clinical trials."
Annovis is developing Buntanetap, a translational inhibitor of neurotoxic aggregating proteins (TINAPs), for the treatment of early and late Parkinson's. An orally available small hydrophobic molecule, Buntanetap improves axonal transport and impedes the toxic cascade. Buntanetap's unique mode of action has been intensively studied and has already successfully concluded two Phase 2 trials - one in AD and one in PD.
Earlier this year, the U.S. Food and Drug Administration provided Annovis guidance and clearance for initiation of two Phase 3 clinical trials of Buntanetap in treating early and late PD patients. The early PD study is designed to enroll 450 PD patients with Hoehn & Yahr scale scores of 1, 2 and 3 and randomize them at 1:1:1 ratio into placebo, 10mg or 20mg Buntanetap once daily on top of their standard of care for six months. Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II and III will be used as primary endpoints, while total MDS-UPDRS and Participant Global Impression of Change will be secondary endpoints. In addition, Wechsler Adult Intelligence Scale (WAIS) coding, plasma biomarkers and Mini-Mental State Examination (MMSE) will be evaluated as exploratory endpoints. The Company plans to start recruiting in 2Q2022.
Buntanetap (previously known as ANVS401 or Posiphen) is an oral translational inhibitor of neurotoxic aggregating proteins (TINAPs), that leads to lower levels of neurotoxic proteins, and consequently less toxicity in the brain. In Phase 2a clinical trials 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 human studies, meeting both the primary and secondary endpoints. Additionally, treatment with Buntanetap resulted in statistically significant improvements 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.
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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