Clene Stock Falls As Lead Asset Fails To Show Survival, Function Benefit In Amyotrophic Lateral Sclerosis Trial

Clene Inc CLNN shares are falling after the company released topline results from the Healey ALS Platform trial of CNM-Au8, an investigational gold nanocrystal suspension, in participants with amyotrophic lateral sclerosis (ALS).
The primary endpoint of change in ALS Functional Rating Scale-Revised scores adjusted for mortality was not significant (2% slowing) at 24 weeks.
Secondary endpoints of Combined Assessment of Function and Survival and slow vital capacity were also not met at 24 weeks across the combined 30 mg and 60 mg CNM-Au8 doses.
Related: Clene Shares Fall Despite Multiple Sclerosis Candidate Showing Neurological Improvements.
Prespecified exploratory analyses of the secondary survival endpoint for the 30 mg dose demonstrated a >90% reduction in risk of death or risk of death/permanently assisted ventilation at 24 weeks.
Clene has selected the CNM-Au8 30 mg dose for continued development in ALS. The CNM-Au8 60 mg dose did not demonstrate a survival benefit.
The full analyses, including data on biomarkers of neurodegeneration and exploratory efficacy results, are expected later in 2022.
CNM-Au8 was well-tolerated, and no drug-related serious adverse events or significant safety findings were reported.
Price Action: CLNN shares are down 42% at $1.61 during the premarket session on the last check Monday.