An IRB is a committee that applies research ethics by reviewing the methods proposed for research to ensure that they are ethical. Such boards are formally designated to approve or reject, monitor, and review biomedical and behavioral research involving humans. The purpose of the IRB is to assure that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in a research study.
The two-part study is designed to treat a combined total of 68 PD and AD patients for 4 weeks with Annovis’ lead compound, ANVS401. The study compares 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 might reverse the toxic cascade and recover normal brain function. In addition to target and pathway engagement, the Phase 2 study will also examine safety and tolerability as well as the effect of ANVS401 on motor impairment and non-motor symptoms in early PD patients and the effect on memory and cognitive function in early AD subjects.
“We are excited to receive IRB approval to move forward with this Phase 2 study in PD and AD,” commented Maria Maccecchini, Ph.D., CEO of
PD affects an estimated one million people in the U.S. and as many as 10 million globally. An estimated 5.8 million people in the U.S. have AD and there are approximately 44 million people worldwide living with the disease. AD and PD significantly impact quality of life for patients and their families.
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
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