Clene (NASDAQ: CLNN) is a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis (“ALS”), Parkinson’s and multiple sclerosis (“MS”). “The company’s lead drug candidate is CNM-Au8, an innovative nanomedicine uniting the principles of physics, chemistry, materials science, and biology to address neurodegenerative diseases from a new angle. Clene uses catalytic boosting of energy metabolism to enable dying neurons to resist the multiple stressors associated with disease, allowing them not only to survive but also to function,” a recent article reads. The article discusses CNM-Au8 development pathways, which have included: a Phase 2 VISIONARY trial in MS; two Phase 2 brain imaging studies, REPAIR-MS and REPAIR-PD, in participants with MS and PD; RESCUE-ALS, a nine-month, Phase 2 study that investigated CNM-Au8 for efficacy and safety in early-stage ALS participants; and a HEALEY-ALS Platform trial, a six-month, Phase 2 study that investigated CNM-Au8 for efficacy and safety in participants with ALS. “During 2024, Clene will work with the U.S. FDA to consider the strength of Clene’s data while exploring all potential pathways to commercialization, including the possibility of accelerated approval based upon a biomarker and/or survival signal. With the supportive efficacy data and additional biomarker data in the pipeline, the company believes that the development path for CNM-Au8 looks bright in 2024.”
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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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