Clene(US:CLNN) Globenewswire·2025-09-25 12:00Core Insights - Clene Inc. and its subsidiary Clene Nanomedicine presented combined results from the REPAIR-MS studies at the 41st Congress of the European Committee for Treatment and Research in Multiple Sclerosis, focusing on the treatment of neurological diseases like ALS and MS [1][5] Group 1: Study Overview - The REPAIR studies, including REPAIR-MS and REPAIR-PD, were Phase 2, open-label studies assessing the effects of CNM-Au8 on neuronal redox state and brain energy metabolism [2] - Participants received 12 weeks of CNM-Au8 treatment followed by a 6-week safety follow-up, with the primary endpoint being the change in brain NAD+/NADH ratio [2] Group 2: Key Findings - The mean NAD+/NADH ratio in the brain increased significantly by +0.449 units (8.65% change) after 12 weeks of treatment across the full REPAIR population [6] - In REPAIR-MS participants, the NAD+/NADH ratio increased by +0.480 units (9.49% change), indicating improved brain energy efficiency [6] - Significant associations were found between baseline measures of cognitive function and brain ATP levels, suggesting a link between energy metabolism and disability in MS [6] Group 3: Safety and Tolerability - CNM-Au8 treatment was reported to be safe and well-tolerated, with adverse events being transient and predominantly mild-to-moderate in severity [7] Group 4: Regulatory Insights - The FDA expressed openness to considering alternative primary endpoints beyond the Expanded Disability Status Scale, including cognitive measures, for evaluating treatment effects in MS [5][8] Group 5: Company Background - Clene Inc. is a late clinical-stage biopharmaceutical company focused on improving mitochondrial health to treat neurodegenerative diseases, with CNM-Au8 being a first-in-class investigational therapy [9][10]