Clene Inc. (NASDAQ: CLNN), in collaboration with its subsidiary Clene Nanomedicine Inc., is making strides in the treatment of neurodegenerative diseases with its lead drug candidate, CNM-Au8. Following constructive feedback from the FDA, the company is preparing to conduct neurofilament biomarker analyses in patients with amyotrophic lateral sclerosis (ALS) as part of its Expanded Access Program. This initiative, expected to begin in early Q4 2025, will focus on evaluating changes in neurofilament light chain (NfL), a key indicator of neurodegeneration, across nearly 200 participants.
The FDA's endorsement of Clene's NfL biomarker analysis plan underscores the potential of CNM-Au8 to offer new hope to individuals battling ALS and other neurodegenerative conditions. Dr. Benjamin Greenberg, Clene's Head of Medical, expressed optimism about the collaborative efforts with the FDA and highlighted upcoming meetings to discuss long-term ALS survival results and End-of-Phase 2 multiple sclerosis (MS) outcomes. These discussions are pivotal for advancing Clene's ALS and MS programs, aiming to deliver innovative therapies that address the urgent need for effective neurodegenerative disease treatments.
CNM-Au8 represents a groundbreaking approach to neurodegenerative disease therapy, targeting mitochondrial health and neuronal function to combat diseases like ALS, Parkinson's, and MS. By focusing on mitochondrial function and the NAD pathway while reducing oxidative stress, CNM-Au8 offers a novel mechanism of action that could significantly improve patient outcomes. The upcoming biomarker analyses and FDA meetings are critical milestones in Clene's mission to bring this promising therapy to market, offering a beacon of hope for patients and families affected by these debilitating conditions.
