Clene Granted In-Person Meeting With FDA Senior Leadership to Discuss CNM-Au8 Biomarker and Related Clinical and Survival Data

SALT LAKE CITY, Sept. 16, 2024 (GLOBE NEWSWIRE) -- Clene Inc. ( CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), announced today that it will meet in-person with the U.S. Food and Drug Administration (FDA) before the end of November 2024 to discuss CNM-Au8 development for ALS.

The meeting will include the FDA’s Director of the Office on New Drugs, the Director of the Office of Neuroscience, and the Division of Neurology 1 (DN1) review team, as well as recognized key opinion leaders in ALS, biostatistics, and biomarkers. Clene is appreciative of the FDA’s use of process and regulatory flexibility to obtain the best outcome for people living with ALS.

By way of background, days prior to DN1 granting the in-person meeting, DN1 communicated that Clene’s briefing package for CNM-Au8 was not supportive of an NDA submission under the accelerated approval pathway. However, after further dialogue, the FDA agreed to meet in person to re-evaluate Clene’s submission under the accelerated approval pathway. Clene looks forward to the opportunity to have experts present their views to the FDA and address questions on ALS biomarkers, related clinical endpoints, and survival data, all of which Clene believes are essential for the understanding of its CNM-Au8.

For CNM-Au8, Clene has more than 700 patient-years of safety data that show no significant safety concerns or safety trends identified. No serious adverse events (SAEs) have been identified as related to CNM-Au8 treatment by any clinical trial investigators to date.

About Clene
Clene 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^® 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^® 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 or follow us on X and LinkedIn.

About CNM-Au8®
CNM-Au8 is an oral suspension of gold nanocrystals developed to restore neuronal health and function by increasing energy production and utilization. The catalytically active nanocrystals of CNM-Au8 drive critical cellular energy producing reactions that enable neuroprotection and remyelination by increasing neuronal and glial resilience to disease-relevant stressors. CNM-Au8^® is a federally registered trademark of Clene Nanomedicine Inc.

Forward-Looking Statements
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