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CNM-Au8® Associated With Delayed Time to Key Clinical Progression Events at Six Months Supporting a Survival Benefit in the Healey ALS Platform Trial
CNM-Au8 associated with a 74% lower risk (lower hazard ratio) of ALS clinical worsening, which included death, non-invasive ventilation >22 hours per day,
About this update from Clene Inc.
[{"type":"text","content":"CNM-Au8 associated with a 74% lower risk (lower hazard ratio) of ALS clinical worsening, which included death, non-invasive ventilation >22 hours per day, tracheostomy, or feeding tube placement (p = 0.035) CNM-Au8 associated with a 98% lower risk of death or permanent assisted ventilation (p= 0.028)CNM-Au8 associated with a 74% lower risk of feeding tube placement (p= 0.035) CNM-Au8 associated with a 63% lower risk of initiation of assisted ventilation (p= 0.058) CNM-Au8 treatment was well-tolerated without significant safety concerns Clene will host a live audio webcast at 7:30 a.m. EST today to review these new clinical results. SALT LAKE CITY, March 09, 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, today announced new results from exploratory analyses including delayed time to key clinical progression events in people living with amyotrophic lateral sclerosis (ALS) who were treated with CNM-Au8® in the HEALEY ALS Platform Trial over the 6-months of the double-blind period. “Analyses of prespecified exploratory endpoints from the HEALEY ALS Platform Trial suggest that treatment with CNM-Au8 delayed time to ALS clinical worsening events across all of the domains, including the need for assisted breathing and placement of stomach feeding tubes. When supported by a confirmatory trial, this would give people living with ALS longer periods of independence, which are precious to them and their families. The consistent nature of the efficacy signal for delayed clinical worsening is highly encouraging and provides new insights supporting the survival benefit seen with the 30mg dose of CNM-Au8. We plan to discuss these findings with the FDA in an end of Phase 2 meeting in order to seek a regulatory pathway towards approval for this significant unmet need,” said Rob Etherington, Clene’s CEO. New Six-Month Findings from HEALEY ALS Platform Trial Regimen C (CNM-Au8): Results are based on prespecified risk adjusted Cox proportional hazards analyses within the population for Regimen C, where treatment with CNM-Au8 30mg over 24-weeks was associated with: A 74% decreased risk (lower hazard) of the composite endpoint of time to A...