Clene Provides Regulatory Update Following Constructive FDA Type-C Meeting on Neurofilament Biomarker Analysis Plan and Confirms Two Additional FDA Meetings

Core Insights - Clene, Inc. and its subsidiary Clene Nanomedicine are focused on developing therapies for neurodegenerative diseases, including ALS and MS, and have provided a regulatory update following a Type C meeting with the FDA [1][4] Regulatory Update - Clene discussed its proposed statistical analysis plan (SAP) for neurofilament light (NfL) biomarker data from its NIH-sponsored Expanded Access Protocol (EAP) involving nearly 200 ALS patients treated with CNM-Au8 [2][6] - The FDA provided constructive feedback on the proposed analysis methodology for assessing NfL change, which will be analyzed after 9 months (primary analysis) and 6 months (supportive analysis) of treatment [2][3] - The acceptance of the SAP by the FDA is expected this summer, establishing a framework for NfL change analyses in EAP participants [3][6] Future Meetings and Plans - Two additional meetings with the FDA are scheduled for the 3rd quarter of 2025 to discuss long-term ALS survival results and the End-of-Phase 2 MS results [4][6] - If the NfL analyses demonstrate a clinically meaningful decline, it may support a new drug application (NDA) submission under the accelerated approval pathway, planned for the end of 2025 [3][6] Product Information - CNM-Au8 is an investigational therapy designed to improve mitochondrial health and protect neuronal function, targeting neurodegenerative diseases [5][8] - The therapy aims to enhance energy production and utilization in central nervous system cells, potentially leading to neuroprotection and remyelination [8]