Clene (NASDAQ: CLNN), through its wholly owned subsidiary Clene Nanomedicine Inc. in collaboration with Columbia University and Synapticure, was awarded a four-year grant totaling $45.1 million from the National Institute of Neurological Disorders and Stroke (“NINDS”), a division of the National Institutes of Health (“NIH”). The grant is to support an Expanded Access Protocol (“EAP”) for the company’s investigational drug, CNM-Au8(R), in amyotrophic lateral sclerosis (“ALS”). Also referred to as Compassionate Use, an EAP is an FDA-regulated pathway that allows people with a serious and life-threatening disease to access an investigational drug that is not yet approved by the U.S. Food and Drug Administration (“FDA”). “This EAP study will give ALS patients who don’t meet the criteria to enroll in a clinical trial an opportunity to try CNM-Au8 as a novel investigational therapy through this EAP program,” said Jinsy A. Andrews, M.D., MSc, FAAN, an associate professor of neurology in the Division of Neuromuscular Medicine and director of Neuromuscular Clinical Trials at Columbia University Vagelos College of Physicians and Surgeons. “Programs like this help to advance research and much-needed innovation in ALS.”
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About Clene Inc.
Clene, along with its subsidiaries and its wholly owned subsidiary Clene Nanomedicine Inc., is a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis, Parkinson’s and multiple sclerosis. CNM-Au8(R) is an investigational first-in-class therapy that improves central nervous system cells’ survival and function via a mechanism that targets mitochondrial function and the NAD pathway while reducing oxidative stress. CNM-Au8(R) is a federally registered trademark of Clene Nanomedicine. The company is based in Salt Lake City, Utah, with R&D and manufacturing operations in Maryland. For more information about the company, visit www.Clene.com.
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