Clene(US:CLNN) Newsfilter·2025-04-08 12:00Core Insights - Clene, Inc. and its subsidiary Clene Nanomedicine, Inc. reported new evidence of remyelination and neuronal repair in multiple sclerosis (MS) patients following treatment with CNM-Au8® 30 mg, as analyzed in the long-term open-label extension of the VISIONARY-MS Trial [1][4][6] Group 1: Clinical Findings - The VISIONARY-MS Trial demonstrated significant improvements in cognition and visual function among MS participants treated with CNM-Au8, supported by objective biomarkers such as advanced MRI Diffusion Tensor Imaging (DTI) and multi-focal Visual Evoked Potential (mf-VEP) assessments [2][3] - Improvements in low contrast letter acuity (LCLA) and symbol digit modality test (SDMT) were observed in CNM-Au8 participants, marking a notable advancement compared to other repair candidate drugs in MS clinical trials [3][5] - Over 90% of participants showing cognitive and visual improvements also exhibited corresponding enhancements in MRI and visual electrophysiology tests [6] Group 2: Biomarker Correlation - MRI DTI metrics, including Axial Diffusivity (AD) and Magnetization Transfer Ratio (MTR), confirmed structural improvements in the neuronal architecture of MS patients treated with CNM-Au8, indicating remyelination and repair [7] - 96% of LCLA responders demonstrated improvements in MRI DTI metrics, while 91% of visual responders exhibited enhancements in mf-VEP metrics, further supporting the link between visual and cognitive recovery and neuronal repair [8] - 98% of SDMT responders with improved cognition had corresponding improvements in MRI DTI metrics, substantiating the association between cognitive enhancement and neuronal repair [8] Group 3: Company Overview - Clene, Inc. is a late clinical-stage biopharmaceutical company focused on therapies for neurodegenerative diseases, including ALS and MS, with CNM-Au8 being a first-in-class investigational therapy targeting mitochondrial function and reducing oxidative stress [9][10]