40 additional patients completed treatment
On track to disclose final safety and efficacy data in early Fall
Toxic cascade markers expected to be disclosed in two to three months
Planning to present all Phase 2a data to the FDA in Q4 2021 and begin Phase 3 in Q1 2022
Berwyn, Pennsylvania, August 11, 2021- Annovis, Bio, Inc. (NYSE: ANVS), a clinical-stage drug platform company addressing Alzheimer’s disease (AD), Parkinson’s disease (PD) and other neurodegenerative diseases, announced today that the company has finished treating an additional 40 PD patients with either 5, 10, 20 or 40 mg once daily of ANVS401 for an extensive dose response study. The original 14 AD and 14 PD patients were treated with either placebo or 80 mg of ANVS401 once daily.
“We closed the study and expect to have final safety and efficacy data to share in the fall and expect to finish analyzing the markers of the toxic cascade in approximately two to three months,” said Maria Maccecchini, PhD, Founder, CEO and President of Annovis Bio. “When we complete our analyses, we plan to summarize our data with our chronic toxicology results in animals and submit it to the FDA ahead of an end-of-Phase 2 meeting. We also look forward to discussing Phase 3 studies in AD and PD with the FDA with the goal of beginning Phase 3 in Q1 2022.”
The data from the first 14 AD and 14 PD patients showed improvements in three steps of the toxic cascade: neurotoxic proteins, axonal health, and inflammation. Additionally, these AD and PD patients showed significant statistical improvements in ADAS-Cog11 and WAIS in AD patients, and MDS-UPDRS and WAIS in PD patients.
For additional details on the clinical trials for ANVS401, including frequently asked questions regarding the data the Company presented at the 2021 Alzheimer's Association International Conference, please visit the Company’s website.
Headquartered in Berwyn, Pennsylvania, Annovis Bio, Inc. 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 Bio, please visit the company's website: .
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," “plan,” "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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