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VISIONARY-MS Trial Results Featured in Platform Presentation at PACTRIMS 2022: CNM-Au8® Demonstrated Global Neurological Improvement in Stable MS Patients as Adjunct to Background Disease Modifying Therapies
CNM-Au8 demonstrated low contrast vision improvement and global neurological improvement (low contrast vision, cognition, upper extremity function, and
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[{"type":"text","content":"CNM-Au8 demonstrated low contrast vision improvement and global neurological improvement (low contrast vision, cognition, upper extremity function, and walking speed) in stable MS patients as adjunct to background immunomodulating disease modifying therapies (DMTs)No approved MS DMTs have shown global neurological improvement in stable MS patients, a significant unmet medical need in MSCNM-Au8 treatment was well-tolerated, and no significant safety findings were observed SALT LAKE CITY, Nov. 28, 2022 (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 that the VISIONARY-MS trial results were featured as a platform presentation by Professor Michael Barnett, MBBS FRACP PhD at the 14th Annual Singapore Pan-Asian Committee on Treatment and Research in Multiple Sclerosis (PACTRIMS) Congress held November 24-26. The platform presentation titled, “VISIONARY-MS Top-line Results: A Phase 2, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Assess the Safety and Efficacy of CNM-Au8, a Catalytically Active Gold Nanocrystal Suspension in Relapsing Multiple Sclerosis,” provided proof-of-concept evidence for global neurological improvement as assessed by the modified Multiple Sclerosis Functional Composite (mMSFC), evaluating low contrast vision, cognition, upper extremity function, and walking speed with CNM-Au8 as adjunct to approved background immunomodulatory disease modifying therapies (DMTs) in stable MS patients. 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 DMTs as background standard of care. The primary endpoint, evaluating change in low contrast letter acuity (LCLA) compared to placebo at week 48, demonstrated significant improvement (mITT population, least squares [LS] mean difference, 3.13; 95% CI: -0.08 to 6.33, p = 0.056).Secondary endpoint of global neurological improvement, the modified Multiple Sclerosis Functional Composite (mMSFC), mean standardized change compared to placebo at we...