Clene's Neurogenerative Candidate Shows Potential For Improved Long-Term Survival

Clene Inc. CLNN released long-term follow-up data for patients treated with CNM-Au8 30mg for up to 133 weeks in the HEALEY ALS Platform Trial. 

These post hoc results showed significantly improved survival with a 49% decreased risk of death for the covariate risk-adjusted analyses as compared to the largest U.S. clinical database of previous amyotrophic lateral sclerosis (ALS) trials (PRO-ACT).

ALS is characterized by progressive degeneration of nerve cells in the spinal cord and brain.

In a pooled analysis of the HEALEY ALS Platform Trial and the RESCUE-ALS Trial, 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; adverse events observed with CNM-Au8 have been characterized as transient and predominantly mild-to-moderate in severity.

In June, Clene reported new data demonstrating a statistically significant reduction of plasma neurofilament light chain (NfL) levels for CNM-Au8 treated participants compared to placebo after 24 weeks in the HEALEY ALS Platform Trial.

CNM-Au8 treatment demonstrated significantly reduced plasma neurofilament light chain levels compared to the placebo at 24 weeks (p=0.04).

The 24-month long-term data cut from the Phase 2 RESCUE-ALS ongoing open-label extension (OLE) showed a significant median survival benefit of 19.3 months and a 52% decreased risk of ALS clinical worsening events with CNM-Au8 treatment.

Price Action: CLNN shares were up 0.22% at $0.46 on the last check Monday.

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