Annovis Bio Expands Potential Application of ANVS401 to Infectious Diseases with New Preclinical Study

Preliminary data shows ANVS401 protects some types of nerve cells from dying after being infected by gingipains, the virulence factors of P. gingivalis

June 08, 2021 8:30 AM EDT | Source: Annovis Bio, Inc.

Berwyn, Pennsylvania--(Newsfile Corp. - June 8, 2021) - Annovis Bio, Inc. (NYSE American: ANVS) ("Annovis" or the "Company"), a clinical-stage drug platform company addressing Alzheimer's disease (AD), Parkinson's disease (PD) and other neurodegenerative diseases, today announced preliminary data demonstrating ANVS401, the Company's lead drug candidate, protects certain nerve cells from dying after being infected by gingipains, the virulence factors of Porphyromonas gingivalis (P. gingivalis), which have been identified as pathogenic effectors in AD.

"We initiated this study last year after filing our patent related to treating neurological injuries due to infections," Maria L. Maccecchini, Ph.D., CEO of Annovis Bio. "Researchers have noted the similarities between many types of infections of the brain, including infections resulting from COVID-19. These short and long-term neurological problems are caused because invasion of the brain by a virus or bacterium causes levels of neurotoxic proteins to rise, which consequently impairs axonal transport, induces inflammation, and leads to nerve cell death. Because ANVS401 has been shown to protect nerve cells against the ill effects of an increase of neurotoxic proteins in the brain, we believe our compound could help with the treatment of neurological diseases associated with bacterial and viral infections, and these latest data support that thesis."

Once the brain is infected with P. gingivalis, two proteases attack and kill nerve cells. Annovis Bio demonstrated that P. gingivalis and its associated proteases infect and kill nerve cells and ANVS401 protects the infected cells from dying. ANVS401 has quite a large impact on the viability of astrocytes in the presence of gingipains. At the concentration of 1nM gingipain infected cells were completely protected from the enzyme while only around 20% of the control cells survived. ANVS401 is shown to protect cells from dying from the P. gingivalis protease Rgp at very low concentrations.

Microglia and neuroblastoma cell lines are not affected as both are quite resistant to gingipains. As expected, since neither are dying, ANVS401 has no impact on the microglia or neuroblastoma survival in the presence of gingipains.

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Annovis Bio is conducting an ongoing Phase 2a clinical trial in AD and PD patients to compare, in both patient populations, how nerve cells die by measuring all the steps in the toxic cascade leading to nerve cell death and how ANVS401 reverses the toxic cascade and recovers normal brain and body function. The data presented today shows that ANVS401 may protect nerve cells from dying due to bacterial infections, furthering the results Annovis Bio has previously shown that ANVS401 protects nerve cells from dying in various animal models, including AD, PD, Down syndrome, stroke, traumatic brain injury, frontotemporal dementia and acute glaucoma.

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 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:

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. 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.

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