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Clene Reports Significant Long-Term Survival Improvement From CNM-Au8 Treatment in HEALEY ALS Platform Trial Compared to PRO-ACT Historical Controls
Prolonged life with 49% decreased risk of death for participants in the HEALEY ALS Platform Trial treated with CNM-Au8® 30mg compared to PRO-ACT matched
About this update from Clene Inc.
[{"type":"text","content":"Prolonged life with 49% decreased risk of death for participants in the HEALEY ALS Platform Trial treated with CNM-Au8® 30mg compared to PRO-ACT matched placebo over long-term follow-up, p=0.046Prolonged life with 59% decreased risk of death for participants in an integrated meta-analysis across HEALEY ALS Platform Trial and RESCUE-ALS Trial with CNM-Au8 30mg compared to PRO-ACT matched placebo over long-term follow-up, p=0.004More than 500 patient years of CNM-Au8 treatment exposure without any identified safety signals SALT LAKE CITY, Sept. 25, 2023 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) through its wholly owned subsidiary Clene Nanomedicine, Inc. (collectively “Clene”), today announced long-term follow-up data for patients treated with CNM-Au8 30mg for up to 133 weeks in the HEALEY ALS Platform Trial. These post hoc results show significantly improved survival with a 49% decreased risk of death for the covariate risk-adjusted analyses compared to the largest U.S. clinical database of previous amyotrophic lateral sclerosis (ALS) trials (PRO-ACT) (hazard ratio: 0.510, 95% CI: 0.263 - 0.987, p=0.046). The HEALEY ALS Platform Trial is a perpetual multi-center, randomized, double-blind, placebo-controlled clinical trial program designed to evaluate the efficacy and safety of multiple investigational products in people living with ALS. Enrollment in the CNM-Au8 Regimen was initiated in the summer of 2020. Participants received CNM-Au8 in addition to ALS standard-of-care and were randomized to the drug or placebo during the 24-week double-blind period. CNM-Au8 was then offered to all participants who were eligible, and 92% elected to continue into the Open Label Extension (OLE). CNM-Au8 30mg was selected as the dosage going forward after the double-blind period. In ALS, clinical studies with shorter double-blind treatment duration such as 24 weeks have used historical placebo controls from prior trials to determine the relative survival benefit of investigational treatment over longer-term follow-up (open label data). The PRO-ACT dataset is derived from pooled ALS clinical trial data from 29 completed Phase 2 and Phase 3 ALS clinical trials. Millions of de-identified longitudinally collected records from more than 11,600 individuals with ALS were standardized across trials and merged to create the Pooled Resource Open-Access ...