CLNN - BioMedNewsBreaks - Clene Inc. (NASDAQ: CLNN) Targeting Confirmatory Support for Existing ALS Trial Data with NIH-Funded EAP Study
Clene’s (NASDAQ: CLNN) wholly owned subsidiary Clene Nanomedicine Inc. and its collaborators, Columbia University and Synapticure, recently received a four-year grant totaling $45.1 million. The grant will support an Expanded Access Protocol (“EAP”) study investigating the safety and efficacy of Clene’s investigational product (“IP”), CNM-Au8, as a treatment for people with amyotrophic lateral sclerosis (“ALS”). “CNM-Au8 is an orally administered gold nanocrystal suspension that is thought to improve mitochondrial health and protect neuronal function to treat neurodegenerative diseases. This IP, which clinical studies have shown is well tolerated, can penetrate the blood-brain barrier, stimulate energy production and utilization, and reduce oxidative stress in cells… Clene has previously demonstrated evidence of consistent safety and improved survival for CNM-Au8 across a broad ALS population in two independent Phase 2 trials and ongoing ALS EAP programs that have enrolled over 200 participants since 2019,” a recent article reads. “This new EAP provides access to CNM-Au8 for more people living with ALS and enables the collection of survival, safety and biomarker data in a population not studied in clinical trials,” Benjamin Greenberg, M.D., MHS, FAAN, head of medical of Clene, is quoted as saying. “These data can help provide confirmatory support for the existing trial data Clene has gathered in its clinical trials.”
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About Clene Inc.
Clene (along with its subsidiaries, “Clene”) 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 disease 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, Inc. The company is based in Salt Lake City, Utah, with R&D and manufacturing operations in Maryland. For more information, please visit www.Clene.com.
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