Clene Nanomedicine Presents Updated Blinded Interim Data from the VISIONARY-MS Phase 2 Study
SALT LAKE CITY, Sept. 11, 2020 /PRNewswire/ -- Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company, today announced the presentation of expanded interim results from the VISIONARY-MS Phase 2 study in stable relapsing multiple sclerosis (RMS) patients with chronic visual impairment. VISIONARY-MS is an ongoing study investigating CNM-Au8, a bioenergetic nanocatalyst under investigation for neuro-reparative and remyelination capabilities. Blinded data were analyzed from all trial participants (combined placebo, low-dose, and high-dose CNM-Au8 treated patients), which demonstrated clinically relevant median improvements across the overall RMS study population in accepted MS functional scales, including low contrast vision. The data will be available starting September 11 at 8:00 a.m. ET as an on-demand e-Poster at the MSVirtual2020: 8th Joint ACTRIMS-ECTRIMS (Americas Committee for Treatment and Research in MS – European Committee for Treatment and Research in MS Meeting), held online September 11-13 (www.msvirtual2020.org).
VISIONARY-MS is a double-blind, randomized, placebo-controlled Phase 2 trial evaluating the efficacy and safety of CNM-Au8 as a remyelinating and neuro-reparative treatment in people who have stable relapsing MS with visual impairment. Enrolled participants must have chronic optic neuropathy, defined as visual impairment with no episodes of acute optic neuritis within the six months prior to enrollment, and non-active disease (i.e., be "clinically stable"), defined as no MS relapses within the prior three months. Concomitant immunomodulatory disease-modifying (DMT) MS therapies are allowed with over 90% of patients receiving approved DMTs as background standard of care. Participants are randomized to low-dose CNM-Au8, high-dose CNM-Au8, or placebo. The primary endpoint is improvement in low contrast letter acuity (LCLA) from baseline to week 24, however, all participants will remain in the double-blind, placebo-controlled treatment period through week 48, until the last participant completes week 24.
The presentation (P0243) titled "VISIONARY-MS: A Phase 2 Clinical Trial of Catalytic Gold Nanocrystals, CNM-Au8, for the Treatment of Chronic Optic Neuropathy" features interim blinded efficacy results from the first 44 enrolled participants on treatment for up to 36 weeks. Through week 36, patients on CNM-Au8 demonstrated notable median improvements in LCLA (n = 21, 42 eyes), as well as the three remaining modified Multiple Sclerosis Functional Composite (MSFC) sub-scales, including Symbol Digit Modalities Test (cognition), 9-Hole Peg Test (upper extremity function), and Timed 25-foot Walk (gait). The available safety data indicate that CNM-Au8 is well-tolerated with most adverse events characterized as mild in severity. No serious adverse events related to study drug have been reported to date. Interim data from the first 34 enrolled patients was previously presented during the Joint NAIMS-MSVISUAL Symposium at the ACTRIMS Forum in February 2020.
"We believe these blinded data, which build upon our ACTRIMS presentation earlier in the year, provide evidence for consistent and relevant clinical improvements across recognized MS functional endpoints on top of current standard of care. This presentation reiterates the progress we hope to achieve in addressing the urgent unmet needs of promoting remyelination and neurorepair for patients with MS," said Robert Glanzman, MD, FAAN, Chief Medical Officer of Clene.
"We are thrilled to present this important efficacy and safety data at a prominent and international MS conference. We will continue to strive to demonstrate the clinical potential of CNM-Au8 and our patented Clean-Surfaced Nanocrystal therapeutics for the treatment of debilitating neurodegenerative diseases," said Rob Etherington, President and CEO of Clene.
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SOURCE Clene Nanomedicine, Inc.