Clene to Meet with FDA Leadership on Potential ALS Treatment

Clene Inc. (NASDAQ: CLNN), a late clinical-stage biopharmaceutical company, has announced an upcoming meeting with U.S. Food and Drug Administration (FDA) leadership to discuss its lead drug candidate CNM-Au8 for the treatment of amyotrophic lateral sclerosis (ALS). The in-person meeting, scheduled to take place before the end of November 2024, marks a significant step in Clene's pursuit of an accelerated approval regulatory pathway for CNM-Au8 in ALS treatment.

The meeting will focus on CNM-Au8's biomarker and related clinical and survival data for ALS. It will be attended by high-ranking FDA officials, including the Director of the Office on New Drugs and the Director of the Office of Neuroscience, as well as key opinion leaders in ALS, biostatistics, and biomarkers. This high-level participation underscores the potential importance of CNM-Au8 in addressing the unmet medical needs of ALS patients.

CNM-Au8 has shown promise in restoring and protecting neurological function, offering hope for patients with neurodegenerative conditions. The drug's potential extends beyond ALS, with possible applications in other neurodegenerative diseases such as multiple sclerosis (MS). The FDA's agreement to reevaluate Clene's submission through this meeting suggests a willingness to consider novel approaches in the treatment of these challenging conditions.

This development is significant for several reasons. First, it represents a potential breakthrough in ALS treatment, a disease for which there are currently limited therapeutic options. Second, the accelerated approval pathway, if granted, could bring CNM-Au8 to patients more quickly, potentially improving outcomes for those living with ALS. Finally, this meeting could set a precedent for the evaluation of innovative treatments for neurodegenerative diseases, potentially opening doors for other companies and therapies in the field.

For investors and the biotech industry, this news signals Clene's progress in its clinical development program and its potential to make a significant impact in the treatment of neurodegenerative diseases. The outcome of this meeting could have far-reaching implications for Clene's market position and the broader landscape of neurological treatments.