Clene Study Demonstrates Prolonged Life for ALS Patients
Clene (Nasdaq: CLNN) has shared long-term follow-up data for patients treated with CNM-Au8 30mg for up to 133 weeks in the HEALEY ALS Platform Trial. The results show significantly improved survival with a 49% decreased risk of death compared to the largest US clinical database of previous amyotrophic lateral sclerosis (ALS) trials.
Improved survival status is considered an important measure of drug effect.
Benjamin Greenberg, M.D., Head of Medical at Clene, said, “To show such profound survival improvement using the HEALEY ALS Platform Trial data set…is remarkable, and helps confirm the survival benefit seen in the prespecified secondary endpoint. Clene is extremely gratified to see this consistent long-term survival data from the HEALEY ALS Platform Trial Open Label Extension, with a continued clean safety profile, adding to the totality of the survival evidence.”
The HEALEY ALS Platform Trial is a perpetual multi-center, randomized, double-blind, placebo-controlled clinical trial program designed to evaluate the efficacy and safety of multiple investigational products in people living with ALS. 92% of patients elected to continue into the Open Label Extension.
Originally randomized CNM-Au8 30mg treated participants (n=59) demonstrated a statistically significant 49% decreased risk of death compared to PRO-ACT matched placebo patients through long-term follow-up.
A pooled analysis of the HEALEY ALS Platform Trial and the RESCUE-ALS Trial showed that participants originally randomized to CNM-Au8 30mg (n=82) demonstrated a statistically significant 59% decreased risk of death compared to PRO-ACT matched placebo patients through long-term follow-up.
No serious adverse events have been assessed as related to CNM-Au8 treatment.
Clene and its wholly owned subsidiary, Clene Nanomedicine Inc., is a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis, Parkinson’s disease and multiple sclerosis. CNM-Au8(R) is a federally registered trademark of Clene Nanomedicine Inc. The company is based in Salt Lake City, Utah, with R&D and manufacturing operations in Maryland. For more information, please visit www.Clene.com.