Clene Inc. has presented clinical results from its REPAIR trials at the ECTRIMS 2025 meeting in Barcelona, asserting that treatment with its investigational therapy CNM-Au8 improved brain energy metabolism in patients with multiple sclerosis (MS).
According to the company, combined Phase 2 data across relapsing MS, non-active progressive MS, and Parkinson’s disease cohorts showed a statistically significant increase in the brain NAD+/NADH ratio after 12 weeks of treatment (mean increase +0.449 units; p = 0.0148). The percent change was 8.65% (p = 0.0006). In the MS sub-population, the NAD+/NADH ratio increased by +0.480 units (p = 0.058) with a 9.49% change (p = 0.0275).
Secondary endpoints purportedly also showed significant increases in NAD+ and decreases in NADH across both the full REPAIR population and the MS subgroup. Baseline correlations were noted between lower NAD+/NADH ratios and higher expanded disability scores, and between brain ATP levels and measures of cognitive processing and motor function. The company claims this reinforces bioenergetic failure as a contributor to neurodegeneration in MS, and that boosting brain energy could slow disability progression.
Clene said that CNM-Au8 was safe and generally well tolerated, with adverse events described as transient and mostly mild to moderate. The company also reports that during a Type B meeting with the U.S. Food and Drug Administration (FDA), the agency acknowledged limitations of the Expanded Disability Status Scale and expressed openness to considering alternative primary endpoints, such as cognition, for broader treatment evaluation.
Clene is a clinical-stage biopharmaceutical company focused on therapies targeting mitochondrial health for neurological diseases.
