Fri, 30 Jul 2021
ANVS401's Interim Clinical Data Demonstrate Statistically Significant Improvements in Cognitive Function in AD Patients and Motor Function in PD Patients
Biomarkers Demonstrate Reduction in Neurotoxic Proteins, Improvement in Axonal Health and Reduction in Inflammation Levels
Next Clinical Data Readout Expected in the Third Quarter
Berwyn, Pennsylvania--(Newsfile Corp. - July 30, 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 said it is pleased by the positive interim results released on July 28 from Phase II clinical trials of its lead compound, ANVS401 (Posiphen).
Over the course of the first 25 days of treatment, the initial patient cohorts demonstrated statistically significant positive results in both their cognitive and motor skills. The biomarkers presented and analyzed to date also corroborate the efficacy of ANVS401.
Maria L. Maccecchini, Ph.D., Founder, CEO and President of Annovis Bio, said, "We were pleased to see improvements in cognition and motor skills in only 25 days and are hopeful we will see cumulative and long-lasting positive outcomes from the use of ANVS401 through the remainder of the trials."
Additional results include:
- AD Patients: In the ongoing study of ADAS-Cog, the ANVS401-treated group showed improvement in all four ADAS-Cog tests performed compared to the placebo group. Specifically, patients treated with ANVS401 showed a 4.7 point or 30% improvement while the placebo group showed a 1.1 point improvement in ADAS-Cog11. Additionally, the WAIS coding test, which measures speed in movement and thinking, found that treated AD patients had a 6.6 point improvement in coding after ANVS401 treatment. In AD patients there were positive trends in MMSE and total CDR score, but the data was not statistically significant.
- PD Patients: In the ongoing study of MDS-UPDRS test, the ANVS401-treated group showed improvement in all four parts of UPDRS test compared to the placebo group. Specifically, PD patients treated with ANVS401 improved 6.2 points (14%) while the placebo group declined 4.2 points. Additionally, the WAIS coding test, which measures speed in movement and thinking, showed that PD patients had a 6.1-point improvement in coding after ANVS401 treatment.
The trial also measured the levels of six neurotoxic aggregating proteins, levels of neurofilament light to show axonal health and of three inflammatory markers that are prevalent in the brains of AD and PD patients. All of the neurotoxic proteins were reduced in AD patients - some reductions were statistically significant, and some were not. Neurofilament light was reduced in both AD and PD patients compared to placebo, although the results were not statistically significant. All of the inflammatory markers showed statistically significant reductions after 25 days of treatment in 14 PD patients. In addition, we determined there was a statistically significant increase in the ratio of Aβ42/Aβ40 among AD patients, suggesting that they improved.
The company expects its next clinical data readout in the third quarter and plans to release the outcome of its review of all the biomarkers of the toxic cascade in the coming months.
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 have two ongoing Phase 2 studies: one in AD patients and one in both AD and PD patients. In the AD/PD study our drug improves memory loss and dementia associated with AD, as well as body and brain function in PD. For more information on Annovis, please visit the company's website: www.annovisbio.com.
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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