- Clene is partnering with APST Research GmbH to analyze neurofilament light chain (“NfL”) data for evaluating CNM-Au8® in ALS patients.
- APST maintains one of the largest ALS biomarker databases, with data from over 4,300 ALS patients, including clinical outcomes and biomarker tracking.
- The analysis will compare NfL changes in the NIH-sponsored Expanded Access Program (“EAP”) participants with historical ALS patient data to assess CNM-Au8’s potential efficacy.
- Clene plans to submit its statistical analysis plan to the FDA, aiming for filing of an NDA for potential accelerated approval in the second half of 2025.
- No significant safety concerns have been reported across over 800 participant years of CNM-Au8 treatment.
Clene Inc. (NASDAQ: CLNN) 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”), has signed an agreement with APST Research GmbH (“APST”) to support analyses of CNM-Au8’s effects on NfL decline in participants in ongoing EAPs (https://ibn.fm/2IwhG). The analyses were recommended by the U.S. Food and Drug Administration (“FDA”) to support Clene’s data package for a potential accelerated approval application.
Based in Germany, APST operates one of the largest ALS biomarker repositories, with data on over 4,300 ALS patients, including demographic information, motor function, and NfL biomarkers. This collaboration will provide Clene with robust comparative data to assess CNM-Au8’s potential efficacy in reducing…
NOTE TO INVESTORS: The latest news and updates relating to CLNN are available in the company’s newsroom at https://ibn.fm/CLNN
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