Clene Receives Positive EMA Opinion on Orphan Drug Designation for CNM-Au8® for the Treatment of ALS

SALT LAKE CITY, July 19, 2022 (GLOBE NEWSWIRE) — Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative disease, today reported that it has received a positive opinion for its submission requesting Orphan Drug Designation for CNM-Au8® for the treatment of amyotrophic lateral sclerosis (ALS) from the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP).

Orphan Drug Designation in Europe is granted for a serious or life-threatening disease affecting not more than five in 10,000 people. Clene would benefit from this designation with protocol assistance, reduced regulatory fees and market exclusivity. The positive opinion for Orphan Drug Designation for CNM-Au8 in ALS was based on data submitted from the Phase 2 RESCUE-ALS trial and preclinical ALS models.

“It is extremely gratifying to receive Orphan Drug Designation in the European Union for the treatment of ALS with CNM-Au8,” said Rob Etherington, President and CEO of Clene. “We are extremely encouraged by the recent statistically significant survival benefit demonstrated by CNM-Au8 in the long-term open-label extension of the RESCUE-ALS trial, and we await top-line data from the HEALEY ALS Platform Trial, which is expected this quarter. We plan to make CNM-Au8 broadly available to patients with this rapidly progressive neurodegenerative disease as soon as possible, and we look forward to working with the European Medicines Agency to advance toward this goal.”

About Clene
Clene is a clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative disease by targeting energetic failure, an underlying cause of many neurological diseases. 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 Twitter, LinkedIn and Facebook.

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.

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Source: Clene Inc.