True test for Clene’s ALS survival comes next

A Phase II survival benefit is raising hopes that CNM-Au8 from Clene may become a long-awaited drug for ALS patients, but the real test will be its performance in the Phase III HEALEY ALS platform study — and data from that trial are expected this quarter. 

In the latest interim analysis of the Phase II RESCUE-ALS open-label extension study of gold nanocrystal suspension CNM-Au8, the Clene Nanomedicine Inc. subsidiary of Clene Inc. (NASDAQ:CLNN) reported that five patients in the CNM-Au8 arm died during the up to 130 months of follow-up, compared with 14 patients in the control arm. That translates to a statistically significant hazard ratio of 0.3 reflecting a 70% decrease in the risk of death (p=0.01). ...