BioMedNewsBreaks — Clene Inc. (NASDAQ: CLNN) Collaborates to Support Potential Accelerated Pathway for ALS Treatment Candidate

Clene (NASDAQ: CLNN) and its wholly owned subsidiary, Clene Nanomedicine Inc., is partnering with APST Research GmbH to analyze neurofilament light chain (“NfL”) data in evaluating its drug candidate, CNM-Au8®, for ALS treatment. Based in Germany, APST operates one of the largest ALS biomarker repositories, which includes data from over 4,300 ALS patients. This collaboration will enable Clene to compare NfL levels in patients treated with CNM-Au8 against historical ALS controls to assess the drug’s potential in slowing disease progression. The goal is to use these findings to support FDA accelerated approval for CNM-Au8 by demonstrating its ability to reduce NfL decline and improve survival rates. Clene is planning to submit a new drug application (“NDA”) to the FDA in the second half of 2025 for potential accelerated approval. The NDA will contain data on NfL changes and survival with CNM-Au8 treatment, bolstered by results of this study. CNM-Au8, an oral suspension of gold nanocrystals, is designed to target mitochondrial dysfunction and promote neuronal health.

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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® 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.

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