Annovis Bio Inc., a clinical-stage drug platform company addressing Alzheimer’s disease, Parkinson’s disease and other neurodegenerative diseases, is pleased to announce it has restarted patient recruitment for its Phase 2a clinical trial in AD which was suspended due to COVID-19 in March 2020, and initiated recruitment for its new Phase 2a clinical trial in AD and PD.
BERWYN, Pa., Aug. 20, 2020 (GLOBE NEWSWIRE) -- 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, is pleased to announce it has restarted patient recruitment for its Phase 2a clinical trial in AD which was suspended due to COVID-19 in March 2020, and initiated recruitment for its new Phase 2a clinical trial in AD and PD.
The Company’s first Phase 2a trial of its lead compound, ANVS401, is a one-month study in 24 AD patients conducted in collaboration with the Alzheimer Disease Cooperative Study. The study is being conducted in six sites, including the University of California, San Diego, Johns Hopkins, Indiana University, Washington University, Cleveland Clinic, and Columbia University. Prior to suspension of enrollment, 14 patients had been enrolled and treated in this trial; patient 15 is expected to be enrolled at the end of August. Data from this trial is expected in 2021.
The second Phase 2a trial is a one-month study that will treat 14 AD and 14 PD patients at 15 sites across the US. Initial data from this trial is expected in early 2021. This study will be followed by a dose response study in 40 PD patients, and the Company expects the final readout by late summer 2021.
“We are excited to be able to recruit patients for both of our Phase 2a trials,” commented Maria Maccecchini, Ph.D., CEO of Annovis Bio. “We have increased the number of trial sites to expedite enrollment and to deliver on our projections as to when we would report data. We look forward to doing so as early as January 2021.”
By fall, the Company also expects to report final data from its NIH-funded long-term toxicology studies, which should further confirm the safety of ANVS401 that has previously been demonstrated in Phase 1 and earlier toxicology studies.
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 an ongoing Phase 2a study in AD patients and have commenced a second Phase 2a study in 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 and the approval of any allowances or additional patents. 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, 2019 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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SOURCE: Annovis Bio, Inc.
