Clene Inc. Advances Regulatory Strategy for CNM-Au8 with FDA Meetings Scheduled for ALS and MS Programs

Clene Inc. (NASDAQ: CLNN) has made significant strides in its regulatory strategy for CNM-Au8, a promising therapy for neurodegenerative diseases, following a productive Type C meeting with the FDA. The company has resubmitted a revised statistical analysis plan (SAP) for evaluating neurofilament light (NfL) biomarker data from its Expanded Access Protocol for amyotrophic lateral sclerosis (ALS), with FDA acceptance anticipated this summer. This development is crucial as it paves the way for NfL analyses in early Q4 2025, supporting a potential New Drug Application (NDA) submission under the accelerated approval pathway.

In addition to the progress in ALS treatment, Clene has scheduled two more FDA meetings in Q3 2025. The first meeting will assess long-term ALS survival data for accelerated approval consideration, while the second, an End-of-Phase 2 Type B meeting, will review Phase 2 multiple sclerosis (MS) trial results and discuss a Phase 3 study aimed at cognitive improvement. These meetings underscore Clene's commitment to advancing treatments for neurodegenerative diseases, offering hope to patients and families affected by these conditions.

CNM-Au8, Clene's investigational first-in-class therapy, is designed to improve central nervous system cells' survival and function by targeting mitochondrial function and the NAD pathway, while reducing oxidative stress. The therapy represents a novel approach to treating neurodegenerative diseases such as ALS, Parkinson's disease, and MS. The upcoming FDA meetings and the potential for accelerated approval highlight the importance of CNM-Au8 in the biopharmaceutical landscape, with implications for future treatment options and the broader fight against neurodegenerative diseases.

For more information on Clene Inc. and its innovative therapies, visit https://www.Clene.com.