Clene Inc. Advances Neurofilament Biomarker Analysis for CNM-Au8(R) in ALS with FDA Support

Clene Inc. (NASDAQ: CLNN) is set to conduct neurofilament biomarker analyses for its lead candidate CNM-Au8(R) 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) during a recent Type C meeting. The analysis will focus on neurofilament light chain (NfL), a biomarker for neurodegeneration, among nearly 200 ALS patients participating in the National Institutes of Health-sponsored Expanded Access Program (EAP) for CNM-Au8. This initiative could pave the way for an accelerated approval submission for CNM-Au8 later in 2025, building on previous results from the HEALEY Platform Trial that showed neuroprotective effects.

The FDA's engagement with Clene includes discussions on a revised statistical analysis plan, with the agency's acceptance expected this summer. Benjamin Greenberg, MD, Head of Medical at Clene, highlighted the FDA's collaborative approach and the potential of CNM-Au8 to offer an innovative therapy for neurodegenerative diseases. Additionally, Clene has scheduled two more FDA meetings in the third quarter of 2025 to discuss ALS survival data and its multiple sclerosis (MS) program, indicating a broader strategy to address unmet needs in neurodegenerative diseases.

CNM-Au8, an oral suspension of gold nanocrystals, is designed to enhance cellular energy production, crucial for neuronal health. The upcoming biomarker study and FDA meetings underscore Clene's commitment to advancing treatments for ALS and MS, where therapeutic options are currently limited. The company's efforts in the EAP and planned analyses reflect a significant step toward validating the therapeutic potential of CNM-Au8, with the hope of achieving regulatory approval and improving outcomes for patients with these challenging conditions.