Clene Reports Reduction in Biomarker Plasma Neurofilament Light (NfL) Levels and Improved Survival With CNM-Au8 Treatment From HEALEY ALS Platform Trial Long-Term Open Label Extension

• CNM-Au8 30mg treatment demonstrated significantly reduced plasma neurofilament light chain (NfL) levels at 76 weeks relative to placebo (18 months from randomization, p=0.023)
  
  
• 60% decreased risk of long-term all-cause mortality (>18 months, p=0.0167) in participants originally randomized to CNM-Au8 30mg compared to those originally randomized to placebo using the rank-preserving structural failure time model (RPSFTM)
  
  
• CNM-Au8 30mg had greater overall treatment effect in delaying the time to morbidity events in the highest risk participants based on baseline NfL levels
  
  
• NfL biomarker and survival data from the long-term open label extension reinforces evidence of a treatment effect consistent with time to event results observed in the original double-blind Phase 2 period
  
  

SALT LAKE CITY, Dec. 21, 2023 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today reported new data from the 12-month long-term open label extension (OLE) of the CNM-Au8 treatment arm in the HEALEY ALS Platform Trial.

Long-Term Plasma NfL Biomarker Findings from Regimen C (CNM-Au8) in the HEALEY ALS Platform Trial Open Label Extension (OLE)

Plasma neurofilament light chain (NfL), a blood-based biomarker associated with neurodegeneration, declined by 16% (95% CI: 2% to 28%) from baseline to 76 weeks of treatment in the HEALEY ALS Platform Trial Open Label Extension (OLE) in participants randomized to CNM-Au8 30 mg relative to participants initially randomized to placebo (p=0.023). CNM-Au8 was associated with a 10% relative reduction in plasma NfL over the 24-week double-blind treatment period of the HEALEY ALS Platform Trial (p=0.040). This effect on NfL appears durable over the long-term follow-up period.  

NfL, a key biomarker of neurodegeneration, is released from neurons following axonal injury, especially in people living with ALS, where higher levels of NfL have been found to predict more rapid decline in clinical function and increased mortality risk. Biomarkers such as NfL that are considered reasonably likely to serve as surrogates of effects on clinical endpoints have recently been used to support an FDA approval of a drug for the treatment of ALS.