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ALS and MS Clinical Data from Clene’s CNM-Au8® Featured in Multiple Presentations at the 2023 American Academy of Neurology Annual Meeting
SALT LAKE CITY, April 25, 2023 (GLOBE NEWSWIRE) -- Clene Inc. (NASDAQ: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene
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[{"type":"text","content":"SALT LAKE CITY, April 25, 2023 (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, announced that CNM-Au8® results in multiple sclerosis (MS) and amyotrophic lateral sclerosis (ALS) were presented in plenary sessions at the 2023 American Academy of Neurology (AAN) Annual Meeting, currently taking place in Boston. The MS platform presentation and ALS survival poster highlight the results from multiple clinical trials that demonstrated clinical benefit and safety of treatment with CNM-Au8, a cellular energetic nanocatalyst. A poster presented by James Berry, MD, MPH, from Massachusetts General Hospital and Harvard University, entitled “Evidence for Survival Benefit in ALS with CNM-Au8 Treatment Across Three Study Populations,” highlighted the consistent survival results seen across broad ALS populations involving different stages of the disease. These findings support the advancement of clinical development of CNM-Au8 in a confirmatory Phase 3 study. Specific highlights of the poster included: Early ALS: Treatment with CNM-Au8 30mg demonstrated a statistically significant survival benefit of 60% and decreased risk of death through 120 weeks versus original placebo randomization.Mid-to-late stage ALS: Treatment with CNM-Au8 30mg was associated with a survival benefit of >90% decreased risk of death or permanent assisted ventilation through 24 weeks versus placebo.Real world experience ALS: Treatment with CNM-Au8 30mg was associated with median survival of greater than three years in an Expanded Access Program. In addition, a plenary presentation by Michael Barnett, Ph.D., from the University of Sydney, highlighted results from the VISIONARY-MS study of CNM-Au8 that show improvements in clinical neurologic function and independent quantitative biomarkers of enhanced axonal integrity, measured by visual evoked potential (mf-VEP) amplitude and MRI diffusion tensor imaging (DTI) fractional anisotropy. The primary and secondary endpoints in the VISIONARY-MS study mITT population demonstrated improved clinical outcomes, independent of an immunomodulatory effect. The prespecified exploratory MRI findings in the VISIONARY-MS study provid...