Business
Clene Nanomedicine Announces Top-Line Results from Phase 2 RESCUE-ALS Clinical Trial
RESCUE-ALS Phase 2 Trial did not meet primary MUNIX biomarker endpoint or secondary FVC endpoint at week 36; MUNIX efficacy signal was observed at week 12
About this update from Clene Inc.
[{"type":"text","content":"RESCUE-ALS Phase 2 Trial did not meet primary MUNIX biomarker endpoint or secondary FVC endpoint at week 36; MUNIX efficacy signal was observed at week 12 (p=0.057)MUNIX trial results demonstrated protection of lower motor neurons in the pre-specified subset of limb onset ALS subjects (Wk12, p=0.0385; Wk36, p=0.0741), which represents approximately 70% of the ALS populationStatistically significant reductions in clinically relevant outcomes including ALS disease progression (p=0.0125), ALSFRS-R responder analysis (p=0.035), and improved ALS specific quality of life (p=0.018)Evidence for potential long-term survival benefit Results for Healey ALS Platform Trial Expected in the Second Half of 2022 SALT LAKE CITY, Nov. 02, 2021 (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 disease with its potential first-in-class catalytically active nanocrystal suspension, today announced top-line data from RESCUE-ALS, a Phase 2 clinical trial evaluating CNM-Au8 as a disease modifying treatment for people with early amyotrophic lateral sclerosis (ALS). The trial did not meet the primary or secondary endpoints – Motor Unit Number Index (MUNIX) and forced vital capacity (FVC) – at week 36. However, an efficacy signal was observed for the MUNIX endpoint at week 12 (p=0.057). Furthermore, in a pre-specified analysis in the subset of limb onset ALS, CNM-Au8 demonstrated a significant treatment effect in MUNIX at week 12 (p=0.0385) and a trend for improvement at week 36 (p=0.0741). Limb onset ALS accounts for approximately 70% of the ALS population. MUNIX is a neurophysiological biomarker that estimates the number of functioning lower motor neurons serving selected muscles. Clinically relevant exploratory endpoints through trial week 36 demonstrated significant benefits with CNM-Au8 treatment, including slowing ALS disease progression (p=0.0125), decreasing the proportion of participants with an ALS Functional Rating Scale Revised (ALSFRS-R) 6-point decline (p=0.035), and improving quality of life as measured by the ALS Specific Quality of Life (ALSSQOL-SF) (p=0.018). In addition, RESCUE-ALS showed evidence for a potential long-term survival benefit when com...