Clene Reports Significant Improvement in Vision and Cognition With CNM-Au8® Treatment in VISIONARY-MS Trial Long-Term Open Label Extension

Core Insights - Clene Inc. reported significant long-term improvements in vision and cognition for participants with stable relapsing multiple sclerosis (RMS) treated with CNM-Au8 over a 35-month period, with p-values indicating strong statistical significance [1][3][7] Group 1: Clinical Trial Results - Long-term CNM-Au8 treatment showed improvement in low contrast visual acuity (LCLA) with a least-square mean difference of +8.70 letters at Week 144 compared to baseline, and +4.0 letters compared to the end of the double-blind period [2][3] - Cognitive improvement was measured by the Symbol Digit Modality Test (SDMT), showing a least-square mean difference of +8.03 at Week 144 versus baseline, and +3.11 compared to the end of the double-blind period [3][4] - Individual participants experienced sustained improvements in LCLA by up to 38 letters and cognitive improvements by up to 35 points, indicating notable enhancements in visual function and cognitive processing speed [2][3][4] Group 2: Study Design and Population - The VISIONARY-MS trial was a Phase 2 multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of CNM-Au8 in participants with chronic optic neuropathy [5] - The trial included nearly all participants (92%) on effective immunomodulatory disease-modifying therapies (DMTs) as background standard of care, with 73 participants randomized and 55 continuing into the long-term extension [5][6] - Placebo participants who transitioned to CNM-Au8 during the long-term extension also showed significant improvements in LCLA and SDMT, consistent with those originally assigned to CNM-Au8 [4][5] Group 3: Company Overview and Future Directions - Clene Inc. focuses on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including multiple sclerosis [8] - The company is reviewing the trial data with prospective pharmaceutical partners interested in MS, indicating potential for future Phase 3 studies [7][8]