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Clene Reports New Data from the VISIONARY-MS Phase 2 Study in Multiple Sclerosis Demonstrating CNM-Au8® Treatment Improved Brain Neuronal Structural Integrity
MRI results reinforce the clinical neurological improvements previously reportedMRI results showed improved brain neuronal structural integrity, independent
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[{"type":"text","content":"MRI results reinforce the clinical neurological improvements previously reportedMRI results showed improved brain neuronal structural integrity, independent of an immunomodulatory effectMRI results consistently favor CNM-Au8 improvement of neuronal integrity and myelin improvement, showing decreased brain deteriorationThe brain improvements in stable MS patients on background therapy are unprecedented SALT LAKE CITY, Feb. 13, 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 MRI results from the Phase 2 double-blinded, 48-week treatment period of the VISIONARY-MS trial in multiple sclerosis (MS) patients. These exploratory MRI results support the previously reported statistically significant clinical improvements in low contrast vision and global neurological function in stable relapsing MS patients reported in the mITT population. 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 MS participants with chronic optic neuropathy. 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) because of 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. The study was designed to investigate the hypothesis that supporting neuronal energy metabolism protects neurologic function in patients with MS. Prior to the initiation of VISIONARY-MS, preclinical data characterized CNM-Au8’s mechanism of action as improving energy metabolism in neurons. Exploratory endpoints, including advanced MRI imaging, within this study were designed to evaluate mechanistic and biological effects of CNM-Au8 treatment. The MRI findings provide evidence of brain neuronal structural integrity assessed by diffusion tensor imaging (DTI) that demonstrated statistically significant results for key metrics of axonal integrity and white matter integrity, independent of an immunomodulatory effect. Results include all participants wit...