Core Insights - Clene, Inc. and its subsidiary Clene Nanomedicine, Inc. announced significant survival benefits from their treatment CNM-Au8® for ALS patients based on new analyses from the HEALEY ALS Platform Trial [1][5] Group 1: Survival Analysis Results - The analysis compared survival rates between participants receiving CNM-Au8 30 mg and those in Regimen A, with a follow-up period of up to 48 months [2] - The CNM-Au8 30 mg group achieved a median survival of 951 days compared to 753 days in the Regimen A group, resulting in a gain of 198 days (6.5 months) [6] - A covariate-adjusted RMST improvement of 124 days (4.1 months) was observed, with statistical significance (p=0.045) [6] Group 2: Enhanced Benefits in Specific Patient Subsets - In participants with baseline serum neurofilament light (NfL) levels > 33 pg/mL, median survival improved from 589 days (Regimen A) to 951 days (CNM-Au8), representing an 11.9 month gain [6] - This group experienced a 44% reduction in mortality risk (Cox HR: 0.556, p=0.006) and an RMST improvement of 197 days (6.5 months) [6] - Among participants meeting the core RESTORE-ALS Trial criteria, median survival improved from 628 days (Regimen A) to 1079 days (CNM-Au8), an increase of 451 days (14.8 months) [6] Group 3: Future Clinical Trials and Strategic Direction - Clene plans to launch the Phase 3 RESTORE-ALS study in mid-2025, which will serve as a confirmatory trial for FDA approval [5][11] - The company aims to discuss these findings with the FDA as part of their commercialization strategy [5]
Clene Demonstrates Strengthened ALS Survival Benefit with CNM-Au8® Treatment