Fri, 03 Sep 2021. In doing so, it is expected that ANVS401 will lower the levels of toxic proteins and improve transport within neurons (axonal transport). Both compounds were originally developed by Torrey Pines Therapeutics and licensed to QR Pharma in 2008. Powered by Madgex Job Board Software. In other words, the study will determine whether ANVS401 can lessen the accumulation of toxic proteins, and whether the reduction achieved leads to improvements in neuronal health and brain function. PD is the second most common neurodegenerative disease after AD and affects the central, peripheral, and enteric nervous systems. We have an ongoing Phase 2a study in AD patients and plan to commence a second Phase 2a study in PD patients. 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. Visit the Parkinsonâs News Today forums to connect with others in the Parkinsonâs community. Trial researchers will evaluate the steps in the toxic cascade that lead to neuron death in both conditions, and assess how ANVS401 affects this cascade. ANVS401, also known as Posiphen, is an oral small molecule that prevents the production of these protein aggregates by interfering with their translation — the process through which a protein is made from a messenger RNA template by ribosomes, the cell's protein-making machinery. The upcoming clinical trial plans to enroll a total of 68 people with Alzheimer’s or Parkinson’s at 15 sites across the U.S. Marisa began working with BioNews in 2018, and has written about science and health for SelfHacked and the Genetics Society of America. Posiphen as a candidate drug to lower CSF amyloid precursor protein, amyloid-β peptide and τ levels: target engagement, tolerability and pharmacokinetics in humans, SILK studies - capturing the turnover of proteins linked to neurodegenerative diseases, The experimental Alzheimer's disease drug posiphen [(+)-phenserine] lowers amyloid-beta peptide levels in cell culture and mice, Modulation of human neural stem cell differentiation in Alzheimer (APP23) transgenic mice by phenserine, Neurotrophic and neuroprotective actions of (-)- and (+)-phenserine, candidate drugs for Alzheimer's disease, Age-dependent neuroplasticity mechanisms in Alzheimer Tg2576 mice following modulation of brain amyloid-β levels, Translational inhibition of APP by Posiphen: Efficacy, pharmacodynamics, and pharmacokinetics in the APP/PS1 mouse, Targeting increased levels of APP in Down syndrome: Posiphen-mediated reductions in APP and its products reverse endosomal phenotypes in the Ts65Dn mouse model, The alpha-synuclein 5'untranslated region targeted translation blockers: anti-alpha synuclein efficacy of cardiac glycosides and Posiphen, The anticholinesterase phenserine and its enantiomer posiphen as 5'untranslated-region-directed translation blockers of the Parkinson's alpha synuclein expression, Synthesis of the Alzheimer drug Posiphen into its primary metabolic products (+)-N1-norPosiphen, (+)-N8-norPosiphen and (+)-N1, N8-bisnorPosiphen, their inhibition of amyloid precursor protein, α-synuclein synthesis, interleukin-1β release, and cholinergi, Translational inhibition of α-synuclein by Posiphen normalizes distal colon motility in transgenic Parkinson mice, Post-treatment with Posiphen Reduces Endoplasmic Reticulum Stress and Neurodegeneration in Stroke Brain, Sequential combined Treatment of Pifithrin-α and Posiphen Enhances Neurogenesis and Functional Recovery After Stroke, Potential Therapies—Small Molecule Boosts for Immune Response, Neurogenesis, Alzheimer's Disease and Its Potential Alternative Therapeutics, Novel 5' untranslated region directed blockers of iron-regulatory protein-1 dependent amyloid precursor protein translation: implications for down syndrome and Alzheimer's disease. by The drug was reported to improve outcomes in rodent stroke models (Yu et al., 2020; Turcato et al., 2018). 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 Alzheimer’s in Down Syndrome (AD-DS). lessen gut problems thought connected to alpha-synuclein buildup, Homeostasis and Parkinson’s: Understanding the 2nd Dopamine Center, $1.8M Earmarked for Cutting-edge Parkinsonâs Research, Preexisting Bipolar Disorder Worsens Parkinsonâs Problems, Patients, Caregivers Asked to Help Adira in Choosing Grant Awards, Sweet Marjoram Tea May Lessen Non-motor Symptoms, Planned Phase 2 Trial of ANVS401, Targeting Toxic Proteins, Moving Forward. The brain levels of ANVS401 necessary to effect optimal function were calculated in both studies and compared with efficacious brain levels from previous studies, showing that a 150 nM concentration of ANVS401 in the brain is sufficient for functional efficacy. RedChip Companies Inc. Its concentration was higher in the brain than in plasma, and the most abundant metabolite was N8-NorPosiphen. Both compounds were originally developed by Torrey Pines Therapeutics and licensed to QR Pharma in 2008. These  accumulations disrupt communication between nerve cells and eventually leads to cell death. In our PD animal studies, ANVS401 lowered levels of α-synuclein and normalized gut motility in two transgenic animal models of PD. PD affects an estimated one million people in the U.S. and as many as 10 million globally. At the last dose, participants undergo blood and CSF sampling. Its lead compound is ANVS401 (Posiphen), an orally administrated drug which purportedly inhibited the synthesis of neurotoxic proteins that are the main cause of neurodegeneration. An IRB is an administrative body responsible for protecting the rights and welfare of human research subjects participating in clinical trials. ANVS401 attacks multiple neurotoxic proteins that result from acute and chronic injury to the brain. Importantly, the data are consistent with prior clinical and preclinical results, the drug's mechanism of action and over 10 years of basic research. In March 2017, QR Pharma started a Phase 1/2 trial to study the effect of Posiphen on APP synthesis in people with early AD. Posiphen-treated PD patients improved on the WAIS coding task, a paper-and-pencil test measuring motor dexterity and cognitive speed compared to placebo. Phenserine also inhibits acetylcholinesterase, while Posiphen does not. Ongoing Open-label Study Cassava Sciences is currently conducting a long-term, open-label, multi-center study of sumifilam 100 mg twice-daily for 12 months. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Both Parkinson’s and Alzheimer’s are characterized by the pathological buildup of clumps of proteins in the brain â specifically, clumps of the protein alpha-synuclein in Parkinson’s, and of beta-amyloid and tau in Alzheimer’s. Chemical Name: (3aR)-1, 3a, 8-trimethyl-1, 2, 3, 3a, 8, 8a-hexahydropyrrolo (2, 3-b) indol-5-yl phenyl-carbamate tartrate ANVS401 has a unique mechanism of action in that it inhibited the translation and, therefore, the levels of several key neurotoxic proteins both in vitro and in vivo including APP, tau and αSYN. The drug was reported to be neuroprotective and neurotrophic in AD mouse models (Lilja et al., 2013; Lilja et al., 2013), and to normalize memory impairment, learning, and synaptic function (Teich et al., 2018). 407-491-4498 There were no serious adverse events. She specializes in cancer biology, immunology, and genetics. The primary outcome is adverse events. Name: Posiphen The Parkinson’s study, conducted by Professor Robert Nussbaum at University of California San Francisco and published in the American Journal of Neurodegenerative Disease, is the first study showing the preclinical efficacy of ANVS401 in improving the colonic motility in mouse models of gastrointestinal dysfunction in early PD. The Alzheimer Disease Cooperative Study group is running the trial at six academic medical centers in the U.S. As of February 2020, 11 participants had enrolled, and no adverse effects were reported (company press release). Pharmacokinetics studies revealed that ANVS401 is more abundant in the brain than in blood, in agreement with its lipophilicity, and the main metabolite is N8-NorPosiphen, a molecule with similar properties as ANVS401. Most common side effects were dizziness, nausea, and vomiting that increased with dose. We expect our treatment to improve memory loss and dementia associated with AD and AD-DS, as well as body and brain function in PD. | ANVS401 had a prolonged effect in reducing APP and all related peptides for at least nine hours after the last dose. A planned Phase 2 clinical trial evaluating ANVS401, Annovis Bio‘s lead investigational therapy for people in the early stages of Alzheimer’s and Parkinson’s disease, has received approval from a central institutional review board (IRB). Previous studies using cells in dishes and animal models of both Alzheimer’s and Parkinson’s have supported the treatment’s efficacy â for instance, ANVS401 was shown to lessen gut problems thought connected to alpha-synuclein buildup in mouse models of Parkinson’s. When this information flow is impaired, the nerve cell gets sick and dies. Posiphen reportedly also blocks translation of α-synuclein mRNA, implying potential application in Parkinson’s disease (Rogers et al., 2011; Mikkilineni et al., 2012; Yu et al., 2013). ANVS401 also resulted in significant improvements in speed, coordination and motor skills in 14 people with Parkinson's disease. It does not provide medical advice, diagnosis or treatment. Part 1 finished in early 2021, and Annovis presented results at the 2021 AAIC on July 28. An estimated 5.8 million people in the U.S. have AD and there are approximately 44 million people worldwide living with the disease. Synonyms: ANVS-401, (+)-phenserine, Posiphen tartrate Facebook Statements in this press release contain “forward-looking statements” that are subject to substantial risks and uncertainties. Pensacola, FL 32502 Found insideIn Electric Brain, world-renowned neuroscientist and author R. Douglas Fields takes us on an enthralling journey into the world of brainwaves, detailing how new brain science could fundamentally change society, separating fact from ... Decoding Darkness takes us deep into the minds and far-flung labs of many a prominent researcher, offering an intimate view of the high stakes of molecular genetics, the revolution that propels it, the obstacles that threaten to derail it, ... Posiphen acts on iron-response element sequences in the 5' untranslated region of APP mRNA to inhibit protein synthesis. The study used a mouse model of AD to examine ANVS401's efficacy, pharmacodynamics, and pharmacokinetics. Other endpoints include pharmacokinetic, functional, and cognitive endpoints. Berwyn, PA - September 3, 2021 (GLOBE NEWSWIRE) - Annovis Bio, Inc. (NYSE: ANVS), a clinical-stage, drug platform company addressing neurodegeneration, such as Alzheimer's disease (AD), Parkinson's disease (PD) and Alzheimer's in Down Syndrome (AD-DS), today announced that an interview with CEO and President Dr. Maria Maccecchini, Ph.D. will air on The RedChip Money . Brain injuries and stresses lead to increases in neurotoxic proteins, impaired axonal transport and nerve cell death - neurodegenerative diseases Company: Annovis Bio. This result demonstrates the ability of ANVS401 to reach the nervous system, and its mechanism of action, the translational inhibition of α-synuclein expression, supporting further development of ANVS401 as a drug for the treatment of PD. In Part 1, 14 AD and 14 PD patients were to be randomized roughly 2:1 to 80 mg Posiphen or placebo, taken daily for 23 to 27 days. The trial was paused from March to October 2020 due to COVID19, and is expected to finish in December 2021. -phenserine is a R-enantiomer (positive isomer) of phenserine, being developed by Annovis Bio (formerly QR Pharma), under a licence from Horizon Therapeutics Primary endpoints are safety, pharmacokinetics in plasma and CSF, and the rate of turnover of CSF Aβ40 using the stable isotope labeling kinetics (SILK) technique (see Paterson et al., 2019). Linked In Target Type: Amyloid-Related (timeline), alpha-synuclein The PD study was funded by the Michael J. Marisa holds an MS in Cellular and Molecular Pathology from the University of Pittsburgh, where she studied novel genetic drivers of ovarian cancer. BERWYN, Pa., April 23, 2020 (GLOBE NEWSWIRE) -- Annovis Bio Inc. (NYSE American: ANVS), a clinical-stage drug platform company addressing Alzheimer’s disease, Parkinson’s disease and other neurodegenerative diseases, published data from its two double-blind, placebo controlled animal studies in Alzheimer’s disease (AD) and Parkinson’s disease (PD) demonstrating in both diseases preclinical efficacy of ANVS401, the company’s lead compound. 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. Ten days of treatment in people with MCI led to reductions in CSF of APP cleavage fragments sAPPα and β, and Aβ42, total tau, and phosphorylated tau, and the inflammation markers YKL-40, complement C3, and MCP-1. Twitter Found insideThis is a rewarding and challenging work." —Publishers Weekly Cystic fibrosis was once a mysterious disease that killed infants and children. The company reported significant reductions by 43 and 28 percent in inflammatory markers sTREM2 and GFAP in treated PD patients; a 55 percent YKL40 reduction did not meet statistical significance. All rights reserved. They include single and multiple dosing in 120 healthy adults and a small proof-of-concept study in five people with MCI. The company links these results to decreases in the amyloid. Adverse effects did not increase significantly at doses of up to 60 mg four times a day for 10 days, at which point Posiphen reached brain concentrations presumed sufficient to inhibit APP production. Translational inhibition of APP by ANVS401 has been shown to reduce APP and its fragments in cell culture, animal models, and mildly cognitively impaired patients, making it a promising drug candidate for the treatment of AD. This second volume follows on from Part I by reviewing the variety of animal models of PD current available (from drosophila to rodents to non-human primate species) and their specific contributions to PD research. “In our AD animal studies, ANVS401 was shown to lower amyloid precursor protein (APP) and all its fragments, and animals fully recovered memory, learning, fear conditioning, and brain function. A panel of CSF biomarkers to be measured spans amyloid and tau pathology, inflammation, and neuronal death. âWe are excited to receive IRB approval to move forward with this Phase 2 study in PD [Parkinson’s disease] and AD [Alzheimer’s disease],â Maria Maccecchini, PhD, the CEO of Annovis Bio, said in a press release. It is dosed by mouth and enters the brain. The study is recruiting 24 participants with a diagnosis of amnestic MCI or probable mild AD, and CSF levels of Aβ42 consistent with AD. The study used two α-synuclein transgenic mouse models to investigate the efficacy of ANVS401 in reversing the gastrointestinal dysfunction, showing that ANVS401 normalizes the colonic motility of both transgenic mouse models, while not affecting the Whole Gut Transit Time (WGTT). This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Results of three Phase 1 studies of Posiphen are published (Maccecchini et al., 2012). In August 2020, Annovis began a Phase 1/2 dose-finding biomarker study in early AD and Parkinson’s disease patients. Translational inhibition of APP by ANVS401 has been shown to reduce APP and its fragments in cell culture, animal models, and mildly cognitively impaired patients, making it a promising drug candidate for the treatment of AD. This Phase 2 study will also assess the safety and tolerability of the investigational medication, as well as its effect on symptoms â including motor impairment and non-motor symptoms in Parkinson’s patients, and memory and cognitive problems in those with Alzheimer’s, the release stated. Marisa Wexler The Alzheimer’s study, conducted by Professor Ottavio Arancio at Columbia University and published in Alzheimer’s & Dementia: Translational Research & Clinical Interventions, is the first study demonstrating the therapeutic efficacy in animals of inhibiting the translation of APP and its fragments in an AD model. Posiphen, also known as ANVS-401, is the pure (+) enantiomer of phenserine. All Rights Reserved. It was also tested in the APP-overexpressing Ts65DN mouse model of Down's syndrome, where 50 mg/kg for 26 days lowered expression of APP and its C-terminal fragments, corrected deficits in axonal transport, and normalized neurotrophin signaling (Chen et al., 2021). The compound reduced α-synuclein expression in brain and gut, and improved intestinal function in the A53T α-synuclein transgenic mouse model of PD (Kuo et al., 2019). The AD patients had a decrease in all amyloid/tau biomarkers, with a 12 percent reduction in pTau, and improvement in the Aβ42/40 ratio. Fox Foundation. In Part 2 of the study, 40 PD patients will receive 5, 10, 20, or 40 mg Posiphen, under the same design as in Part 1. For more information on Annovis, please visit the company’s website: www.annovisbio.com. This site is strictly a news and information website about the disease. Participants will be treated with ANVS401 for four weeks. Copyright © 1996–2021 FBRI LLC. The neurodegeneration biomarker NfL had 13 percent lower levels in AD and 9 percent in PD, but the change was not statistically significant. The study is expected to finish in September 2021. 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. Both Posiphen and phenserine reduce production of amyloid precursor protein by blocking translation of its mRNA. Suite 700 ANVS401, also known as Posiphen, is an oral small molecule that prevents the production of these protein aggregates by interfering with their translation â the process through which a protein is made from a messenger RNA template by ribosomes, the cell’s protein-making machinery. For details on Posiphen trials, see clinicaltrials.gov. Condition(s): Alzheimer's Disease, Parkinson's Disease It reduced APP and Aβ in neuronal cultures and brains of wild-type and AD transgenic mice (Lahiri et al., 2007; Marutle et al., 2007). 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, 2019 filed with the Securities and Exchange Commission. Both Posiphen and phenserine reduce production of amyloid precursor protein by blocking translation of its mRNA. 3 W Garden St To make a comment you must login or register. Among its duties, the IRB reviews a trial’s proposed design and purpose to ensure they are up to ethical standards. It was recently patented by Annovis. U.S. FDA Status: Alzheimer's Disease (Phase 2), Parkinson's Disease (Phase 1/2) Phone: 1-800-936-1363. Dave Gentry, CEO Together, these data are very exciting and provide strong support for moving forward in our development of ANVS401 for both AD and PD.”. Dave@redchip.com, © 1985 - 2021 BioSpace.com. Annovis was. “No drug to date has shown efficacy in two totally different animal models of neurodegeneration,” commented Maria Maccecchini, Ph.D., CEO of Annovis Bio. On exploratory efficacy measures, the company claimed a statistically significant within-subject improvement in the ADAS-Cog11 from baseline to 25 days, but the comparison with placebo group fell short of significance. âWe believe we remain on track to complete the study by the first quarter of 2021.â. Email: [email protected] They are randomized to receive 60, 120, or 180 mg daily, divided into three doses, or placebo for 23 to 25 days. "A fascinating look at the gendering of smart homes, how they came to be so, and how modern households can and should be domains of equality"-- In the study, ANVS401 treatment normalized impairments in spatial working memory, contextual fear learning, and synaptic function in APP/presenilin-1 mice, without affecting their visual activity, motor skills, or motivation and without affecting wild-type mice. 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 ANVS401 clinical trials. Posiphen, also known as ANVS-401, is the pure (+) enantiomer of phenserine. RSS Never disregard professional medical advice or delay in seeking it because of something you have read on this website. She also writes/composes musicals and coaches the University of Pittsburgh fencing club. The authors of the New York Times bestseller Super Brain present a bold new understanding of our genes and how simple changes in lifestyle can boost genetic activity. The study used a mouse model of AD to examine ANVS401’s efficacy, pharmacodynamics, and pharmacokinetics. The company thinks that this concerted targeting of multiple neurotoxic proteins may improve. July 8, 2020. Therapy Type: Small Molecule (timeline) Gastrointestinal dysfunction is a particularly common non-motor abnormality in PD, documented in over 80% of patients. Found insideThis book will inspire you to change the way you think about the world and your relationship to everything in it. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. The last dose, participants undergo blood and CSF sampling improvements in speed, coordination motor! 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