Clene reports ‘significant’ survival results from two analyses of CNM-Au8

Clene reported new, significant survival results from two independent analyses of the pooled data from the intermediate-size EAPs supported by Clene. People living with ALS who were generally too advanced in their disease to qualify for clinical trials received daily oral CNM-Au8 30 mg for up to four years to date. A pooled survival analysis of EAP participants treated with CNM-Au8 30 mg was compared to two independent datasets derived from PRO-ACT and the ALS/MND Natural History Consortium. The EAP dataset was comprised of 256 participants with ALS of which 220 EAP participants had all baseline values available for matching. These participants were matched for similar baseline characteristics compared to each non-CNM-Au8 treated control. The results in the EAP participants versus the matched controls demonstrated a significant survival benefit for each comparison: The PRO-ACT dataset is the largest publicly available repository of longitudinal ALS clinical trial data, containing more than 12,000 records of trial participants: CNM-Au8 EAP vs. PRO-ACT matched controls: The baseline risk-adjusted hazard ratio demonstrated a 68% decreased risk of all-cause mortality with CNM-Au8 treatment. The ALS/MND Natural History Consortium data set contained approximately 1,700 records of people living with ALS from researchers across nine academic sites collecting recent real-world data: CNM-Au8 EAP vs. ALS/MND Natural History Consortium matched controls: The baseline risk-adjusted hazard ratio demonstrated a 57% decreased risk of all-cause mortality with CNM-Au8 treatment.