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Clene Announces Updated VISIONARY-MS Phase 2 Trial Data Presented at 2023 ACTRIMS Forum Show CNM-Au8® Demonstrated Significant Improvements in Clinical Outcomes, Brain Structure, and Visual System
Positive clinical results demonstrated in stable relapsing multiple sclerosis patients adjunctive to immunomodulatory disease modifying therapy was previously
About this update from Clene Inc.
[{"type":"text","content":"Positive clinical results demonstrated in stable relapsing multiple sclerosis patients adjunctive to immunomodulatory disease modifying therapy was previously reportedUpdated Visual Evoked Potential (VEP) findings provide evidence of improved information signaling from the eye to the brain’s visual cortex These significant VEP results alongside the previously reported significant MRI results add to the totality of evidence supporting the clinical benefits of CNM-Au8 CNM-Au8 treatment was well-tolerated, and no significant safety findings were observed SALT LAKE CITY, Feb. 27, 2023 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative diseases, today announced updated results from the VISIONARY-MS Phase 2 trial were presented this weekend at the 8th annual Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2023. The poster titled, “CNM-Au8 Phase 2 VISIONARY-MS Updated Trial Results,” contributes to the growing body of evidence supporting improvements in clinical neurologic function and significant paraclinical MRI and VEP findings. The VEP and MRI analyses presented were prespecified exploratory endpoints. VISIONARY-MS investigated the efficacy and safety of CNM-Au8 (15 mg or 30 mg daily) versus placebo over 48 weeks in stable relapsing remitting multiple sclerosis (MS) patients with chronic optic neuropathy. The study was designed to investigate the hypothesis that supporting neuronal energy metabolism protects neurologic function in patients with MS. Nearly all participants (92%) were treated with highly effective disease modifying therapies (DMT) as background standard of care. Due to limited enrollment, 73 of 150, attributed to the COVID pandemic, the threshold for significance was pre-specified at p=0.10 prior to database lock and submitted to the FDA in the statistical analysis plan. Clene announced the topline results of the study in August 2022. Updated VEP Results The updated multi-focal Visual Evoked Potential (mf-VEP) findings provide evidence of improved information transmission in the visual system (from the eye to the visual cortex) supported by statistically significant increases in amplitude....