FDA Clears Neuraly to Begin Phase 2 Trial of NLY01 in Alzheimer’s Patients

FDA Clears Neuraly to Begin Phase 2 Trial of NLY01 in Alzheimer’s Patients
The U.S. Food and Drug Administration has given clearance for a Phase 2B clinical trial to evaluate the safety, tolerability, and efficacy of Nueraly's investigational therapy NLY01 in people with Alzheimer's disease. The randomized, double-blinded, placebo-controlled trial is expected to enroll more than 500 people with mild cognitive impairment due to Alzheimer’s disease at more than 100 sites in the U.S., Canada, and Europe. Results from the trial are expected by the end of 2023. "Initiation of this Phase 2 study in Alzheimer’s disease represents an important milestone in the ongoing advancement of NLY01," Seulki Lee, PhD, president and CEO of Neuraly, said in a press release. NLY01, which was initially developed by researchers at Johns Hopkins University, works by activating a protein called glucagon-like peptide-1 receptor. This protein is highly expressed on microglia — a type of immune cell in the brain that plays a central role in controlling brain inflammation. Inflammation in the brain, called neuroi
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