Clene Inc. Advances Neurodegenerative Disease Treatment with FDA-Backed Biomarker Analysis

Clene Inc. (NASDAQ: CLNN), in collaboration with its subsidiary Clene Nanomedicine Inc., is moving forward with neurofilament biomarker analyses for its leading drug candidate, CNM-Au8, in amyotrophic lateral sclerosis (ALS) patients. This initiative follows constructive feedback from the FDA during a recent Type C meeting, highlighting a collaborative effort to advance treatment options for neurodegenerative diseases. The analyses, scheduled for early Q4 2025, will evaluate changes in neurofilament light chain (NfL), a key indicator of neurodegeneration, among nearly 200 participants from the Expanded Access Program for CNM-Au8.

Dr. Benjamin Greenberg, Head of Medical at Clene, expressed optimism about the FDA's supportive stance and the upcoming discussions on long-term ALS survival results and End-of-Phase 2 multiple sclerosis (MS) outcomes. These developments underscore Clene's commitment to pioneering therapies that address the critical needs of individuals suffering from ALS, Parkinson’s disease, and MS. CNM-Au8 represents a novel approach to enhancing mitochondrial health and neuronal function, offering hope for improved patient outcomes.

For further details on Clene's groundbreaking work, visit https://ibn.fm/t3Lli. The company's dedication to innovation in the biopharmaceutical sector is poised to make a significant impact on the treatment of neurodegenerative diseases, providing a beacon of hope for patients and families affected by these challenging conditions.