Clene Inc. (NASDAQ: CLNN) is set to conduct neurofilament biomarker analyses for its lead candidate CNM-Au8 in amyotrophic lateral sclerosis (ALS) patients early in the fourth quarter of 2025, following supportive feedback from the U.S. Food and Drug Administration (FDA). This analysis could pave the way for an accelerated approval submission later in the year, marking a significant step forward in the treatment of neurodegenerative diseases.
The company's plan involves examining changes in neurofilament light chain (NfL), a key biomarker for neurodegeneration, among nearly 200 ALS patients participating in the National Institutes of Health-sponsored Expanded Access Program for CNM-Au8. The FDA's constructive feedback on Clene's proposed statistical analysis plan during a recent Type C meeting has been a positive development for the company.
Benjamin Greenberg, MD, Head of Medical at Clene, expressed optimism about the FDA's collaborative approach and the potential for CNM-Au8 to offer a new treatment option for ALS patients. The company is also preparing for two additional FDA meetings in the third quarter of 2025 to discuss ALS survival data and its multiple sclerosis (MS) program, further underscoring the potential of CNM-Au8 in treating neurodegenerative diseases.
A successful outcome from the NfL biomarker analysis could significantly enhance Clene's application for accelerated approval, building on previous positive results from the HEALEY ALS Platform Trial. The company's efforts represent a hopeful advancement for ALS patients, for whom treatment options remain limited.
Clene's commitment to improving mitochondrial health and protecting neuronal function extends beyond ALS, with ongoing research into multiple sclerosis. The company's upcoming discussions with the FDA regarding its MS program highlight the broad potential of CNM-Au8 in addressing the challenges of neurodegenerative diseases.
