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.
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