Clene Syas Significant Long-term Survival Improvement For ALS Patients In HEALEY ALS Platform Study

(RTTNews) - Clene Inc. (CLNN), a unit of Clene Nanomedicine Inc., Monday announced long-term follow-up data showing significant long-term survival improvement in patients treated with CNM-Au8 30mg in the HEALEY ALS Platform Trial.

CNM-Au8 is a gold nanocrystal suspension currently in development as a disease-modifying treatment for people living with Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), and Parkinson's Disease (PD).

The HEALEY ALS Platform Trial is designed to evaluate the efficacy and safety of multiple investigational products in people living with ALS, a motor neuron disease characterized by progressive degeneration of nerve cells in the spinal cord and brain. Participants of the trial received CNM-Au8 in addition to ALS standard-of-care and were randomized to the drug or placebo during the 24-week double-blind period. CNM-Au8 was then offered to all participants who were eligible, and 92% elected to continue into the Open Label Extension (OLE).

The analysis showed that 59 participants who were originally randomized to CNM-Au8 30mg demonstrated a statistically significant 49% decreased risk of death compared to PRO-ACT matched placebo patients through long-term follow-up.

PRO-ACT (Pooled Resource Open-Access ALS Clinical Trials) dataset is derived from pooled ALS clinical trial data from 29 completed Phase 2 and Phase 3 ALS studies.

In a pooled analysis of the HEALEY ALS Platform Trial and the RESCUE-ALS Trial, 82 participants originally randomized to CNM-Au8 30mg demonstrated a statistically significant 59% decreased risk of death compared to PRO-ACT matched placebo patients through long-term follow-up.

RESCUE-ALS was a Phase 2 trial that originally randomized 45 people living with ALS, who were an average of 16 months from symptom onset.