Berwyn, Pennsylvania--(Newsfile Corp. - May 19, 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 results from its double-blind, placebo-controlled trial for ANVS401, its lead drug candidate for the treatment of PD and AD. The levels of inflammatory markers in PD patients treated with ANVS401 were significantly lower than before treatment.
"These positive results confirm ANVS401's potential to be a meaningful treatment for neurodegeneration. Our study reveals a highly statistically significant lowering of inflammatory markers in Parkinson's disease patients, which is one step in reversing the toxic cascade," said Annovis Bio CEO Dr Maria Maccecchini, PhD. "Today's news combined with our previous study results revealing ANVS401 increases speed, coordination and motor function in PD patients mark important milestones, as we continue to pursue a novel approach and therapy to fight Parkinson's and Alzheimer's diseases."
"Our hypothesis is that nerve cells die because high levels of neurotoxic proteins impair axonal transport, increase inflammation and eventually lead to nerve cell death and permanent loss of function. When we administer our drug, we expect a reversal of this toxic cascade leading to efficacy. Inflammation is a very important step in the toxic cascade, because it lasts for years and takes over the entire brain. Therefore, reversing inflammation means that we have reversed at least one step of the toxic cascade leading to nerve cell death."
Inflammatory Markers
The trial measured four inflammatory markers that are very prevalent in the brains of AD and of PD patients. Each of the inflammatory markers showed statistically significant reduction after 25 days of treatment with ANVS401 as compared to baseline.
| Inflammatory Marker | % Change from Baseline | p-Value |
| Complement C3 | -24.9 | 0.0072 |
| YKL40 | -22.9 | 0.0213 |
| sTREM2 | -28.2 | 0.0108 |
| GFAp | -34.6 | 0.000001 |
"The inflammatory marker data presented here substantiates and confirms the efficacy of ANVS401 in PD patients we reported in March," noted Dr. Maccecchini.
Next Steps
The cerebral spinal fluid and plasma samples of the 14 PD patients and the 14 AD patients who completed treatment are still being analyzed to measure the reversal of the toxic cascade with additional data expected to be reported in the next two months. The full study data, including a dose ranging analysis in 40 PD patients, is anticipated in July or August of this year.
Following completion of the Phase 2a trial, Annovis Bio will request a meeting with the FDA to present the results of the trial and its chronic toxicology study in animals. Annovis Bio believes today's data and prior clinical results support the potential advancement of ANVS401 into late-stage studies, which the Company is targeting in late 2021, assuming successful completion of its ongoing Phase 2a study.
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 and that the data reported herein is interim data, conclusions as to which may be superseded by subsequent data we expect to receive in connection with Phase 2a trials and/or subsequent clinical trials. 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:
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RedChip Companies Inc.
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SOURCE: Annovis Bio, Inc.
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