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Clene Reports Significantly Improved Survival Benefit of 19.3 Months and Significantly Delayed Clinical Worsening in Rescue-Als Open-Label Extension Two Year Follow-Up
19.3 month significant survival difference for CNM-Au8® treated participants versus placebo52% significant decreased risk of ALS clinical worsening events
About this update from Clene Inc.
[{"type":"text","content":"19.3 month significant survival difference for CNM-Au8® treated participants versus placebo52% significant decreased risk of ALS clinical worsening events Over 475 years of CNM-Au8 treatment exposure without any identified safety signals SALT LAKE CITY, Aug. 29, 2023 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) through its wholly owned subsidiary Clene Nanomedicine Inc., today announced the 24-month long-term data cut from the Phase 2 RESCUE-ALS ongoing open-label extension (OLE) as of July 2023, which showed a significant median survival benefit of 19.3 months using the rank-preserving structural failure time model (RPSFTM) and a significant 52% decreased risk of ALS clinical worsening events with CNM-Au8® treatment. RESCUE-ALS was a 36-week double-blind placebo-controlled Phase 2 trial that originally randomized 45 people living with ALS, who were an average of 16 months from symptom onset. Thirty-six participants entered the long-term open-label extension, which included 20 participants originally treated with CNM-Au8 during the blinded period and 16 placebo-treated participants who were subsequently switched to CNM-Au8 during the start of the OLE. Survival status was available for all 45 participants. Survival Improvement: Cross-over adjusted median survival (RPSFTM, all study participants, post hoc): 19.3 month median survival benefit (CNM-Au8 median survival of 34.2 months, placebo-adjusted median survival of 14.9 months).75% decreased risk of long-term all-cause mortality in participants originally randomized to treatment with CNM-Au8 compared to those originally randomized to placebo after adjusting for benefit received by placebo after switching to CNM-Au8 (HR= 0.252, 95% CI: 0.106 to 0.597; bootstrap log-rank p","length":2225,"tagName":"div"}]