Clene Nanomedicine Presents Updated Interim Data from Phase 2 Multiple Sclerosis Programs at ACTRIMS Forum 2021
- Blinded interim data from VISIONARY-MS continue to support the potential of CNM-Au8 to drive meaningful neurological functional improvements in MS patients
- Interim REPAIR-MS results provide further evidence of CNM-Au8’s homeostatic effect on brain bioenergetics in MS patients
SALT LAKE CITY, Feb. 25, 2021 (GLOBE NEWSWIRE) -- Clene Inc. (NASDAQ: CLNN) (along with its subsidiaries, “Clene”) today announced that its wholly owned subsidiary Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company, will present blinded interim data from its VISIONARY-MS study and updated interim data from its REPAIR-MS study in on-demand presentations at the Americas Committee for Treatment and Research in Multiple Sclerosis (“ACTRIMS”) ACTRIMS Forum 2021 taking place virtually from February 25-27, 2021. Together, these complementary Phase 2 studies evaluate the efficacy, safety, and central nervous system (CNS) metabolic effects of Clene’s lead drug candidate CNM-Au8, a bioenergetic nanocatalyst, in multiple sclerosis (MS) patients.
Updated blinded interim data from VISIONARY-MS, a double-blind, placebo-controlled Phase 2 trial evaluating the efficacy and safety of CNM-Au8 as a remyelinating and neuro-reparative treatment in MS patients will be presented. The analyses compare changes in Multiple Sclerosis Functional Composite (MSFC) scores over the study treatment period to the baseline values of study participants with mild disease, as defined by Baseline Expanded Disability Status Scale (EDSS) scores of 1.5 or less. Notably, baseline scores for these participants demonstrate less neurological impairment than those of the overall study population, providing a valid comparator group. Changes in the four MSFC sub-scales (low contrast letter acuity, symbol digit modalities test, 9-hole peg test, and timed 25-foot walk) were compared to baseline scores of the comparator group with mild disease. These comparisons were performed at each study time-point (Weeks 12, 24, and 36). At each visit, the overall study population (randomized 2:1 active CNM-Au8 to placebo) showed notable increasing mean improvements in overall MSFC scores and key MSFC sub-scales compared to the comparator group (mixed-effects model; p
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