Clene and its wholly owned subsidiary Clene Nanomedicine reported new CNM-Au8 results from the long-term open label extension of the VISIONARY-MS trial in participants with stable relapsing multiple sclerosis totaling nearly three years of follow-up. After completion of the double-blind period, study participants were offered to continue on CNM-Au8 30mg for up to an additional 96-weeks in the LTE. Analyses are reported for the modified intent to treat population that included all study participants with valid clinical data. Progressive Vision Improvement: Low contrast vision demonstrated sustained improvement by up to 38 letters across both eyes in individual participants, which represents multiple row gains on a greyed-out MS eye chart. Progressive Cognitive Improvement: Cognitive improvement, particularly working memory and information processing speed, was improved by up to 35 points in individual participants, where a three-point change in cognitive processing speed has been deemed notable in other MS studies. Improvements demonstrated during the 48-week double-blind period were maintained in the LTE for timed 25-foot walk test and nine-hole peg test. Placebo participants who transitioned to CNM-Au8 during the LTE showed significant improvements versus original baseline in LCLA and SDMT that were generally consistent with the increases observed in participants originally randomized to CNM-Au8.
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