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

Clene Inc. (NASDAQ: CLNN) is progressing with a neurofilament biomarker analysis for its lead candidate CNM-Au8 in amyotrophic lateral sclerosis (ALS) patients, with the U.S. Food and Drug Administration (FDA) providing supportive feedback during a recent Type C meeting. The analysis, scheduled for early Q4 2025, could bolster the case for an accelerated approval submission later that year. The study will focus on neurofilament light chain (NfL) levels among nearly 200 ALS patients participating in the NIH-sponsored Expanded Access Program (EAP) for CNM-Au8, comparing them to matched controls to validate the drug's neuroprotective effects.

Benjamin Greenberg, MD, Head of Medical at Clene, highlighted the FDA's collaborative approach and the potential of the NfL biomarker analysis to advance the company's ALS and multiple sclerosis (MS) programs. With two additional FDA meetings planned for Q3 2025 to discuss ALS survival data and MS program progress, Clene is optimistic about the future of CNM-Au8. The drug, an oral suspension of gold nanocrystals, aims to improve cellular energy production, offering hope for ALS patients with limited treatment options.

Clene's efforts extend beyond ALS, with its MS program also gaining momentum. The company anticipates discussing Phase 2 data from the VISIONARY-MS trial with the FDA, setting the stage for a Phase 3 study focused on cognitive outcomes. The FDA's engagement across Clene's programs underscores the potential of CNM-Au8 to address critical unmet needs in neurodegenerative diseases.