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Annovis Bio to Study Potential of ANVS401 to Normalize Brain Development in Down Syndrome

Collaborative mice study with UC San Diego to study brain development from embryo to old age

Berwyn, Pennsylvania--(Newsfile Corp. - April 29, 2021) - Annovis Bio Inc. (NYSE American: ANVS), a clinical-stage drug platform company addressing Alzheimer's disease (AD), Parkinson's disease (PD) and other neurodegenerative diseases, today announced a new research collaboration with Professor William Mobley and Dr. Xuqiao Chen at the University of California San Diego designed to study the ability of the Company's lead compound, ANVS401, to normalize brain development in Down Syndrome (DS) mice.

"While we know quite a bit about how the brain degenerates in the later stages of life, extraordinarily little is known about how neurodegeneration may start very early in life. We, therefore, plan to look at the brain in embryonic development in DS mice," said Maria Maccecchini, Ph.D., Founder and Chief Executive Officer.

The study will dose healthy and DS female mice starting before fertilization with either placebo or ANVS401 and follow the mother through pregnancy to lactation and the fertilized egg from embryo through old age. At different points, the study will measure levels of various neurotoxic proteins, axonal transport, and inflammation in the brains of the mothers and the offspring to see the differences between a healthy brain, a DS brain, and an ANVS401-treated DS brain. The study will also measure learning and cognition throughout the life span of the mice and will obtain interim data at every step of development while following the mice into old age.

"It is commonly understood that those with DS have elevated amyloid which in turn induces the toxic cascade that ultimately drives AD. What is not yet known is the impact on early brain development. Through this study we hope to gain a clearer understanding of brain development and how ANVS401 could play a much earlier role for DS and other patients," continued Dr. Maccecchini.

The study will be led by Dr. Mobley, associate dean for neuroscience initiatives at UC San Diego School of Medicine, the Florence Riford Chair for Alzheimer's Research, and director of the Down Syndrome Center for Research and Treatment (DSCRT). Dr. Mobley is one of the world's foremost experts on the neurobiology of Down Syndrome, and the DSCRT is one of the first programs in the country to connect academic researchers with treatment of adults and children with Down Syndrome.

"We are thrilled to have access to an excellent model of brain development, a great laboratory to collaborate with, and to be able to follow brain development through the life of a mouse. Ultimately, we hope to generate positive data that demonstrates the potential of ANVS401 to normalize brain development in DS," said Dr. Maccecchini.

In September 2020, Annovis announced the publication of peer-reviewed data demonstrating the ability of its lead candidate, ANVS401, also known as Posiphen, to improve axonal transport, the information highway of nerve cells. The publication, "Targeting increased levels of APP in Down syndrome: Posiphen-mediated reductions in APP and its products reverse endosomal phenotypes in the Ts65Dn mouse model," was published in Alzheimer's & Dementia: The Journal of the Alzheimer's Association., and the study was conducted at UCSD in Dr. Mobley's lab.

AD and DS share several characteristics, including high levels of neurotoxic proteins; specifically, amyloid precursor protein (APP), its C-terminal fragment, phospho-tau and alpha-synuclein. High levels of these proteins impair the transport of vesicles carrying neurotrophic factors. The resulting AD pathology is driven by compromised transport of neurotrophic signals. Treatment of DS mice with ANVS401 normalized levels of neurotoxic proteins and reversed deficits in axonal transport, regulated brain homeostasis, lowered inflammation, and normalized mouse behavior.

About Annovis Bio

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). 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. 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. We have two ongoing Phase 2a studies: one in AD patients and one in both AD and PD patients. For more information on Annovis, please visit the company's website: www.annovisbio.com.

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 ANVS401 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, including that clinical trials may be delayed. 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, 2020 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.

Investor Relations:
Dave Gentry, CEO
RedChip Companies Inc.
407-491-4498
Dave@redchip.com

SOURCE: Annovis Bio, Inc.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/82263

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