Clene Reports New CNM-Au8 Biomarker And Clinical Efficacy Data Submitted To FDA In Support Of Treatment For ALS

Author: Benzinga Newsdesk | August 06, 2024 08:07am

• CNM-Au8 treated participants in the HEALEY ALS Platform Trial with substantial neurofilament light (NfL) declines (CNM-Au8 NfL Responders) demonstrated significant clinical improvements in survival, functional status (slowed ALSFRS-R decline), and combined function and survival (CAFS scores) compared to NfL non-responders
  
  
  • Independent of NfL responder status, significant survival benefits in CNM-Au8 30mg treated participants were observed in the long-term extension compared to matched natural history controls
• Nicotinamide adenine dinucleotide (NAD) and glutathione improvements were consistent and sustained with CNM-Au8 treatment, supporting a dual mechanism of action and indicating target engagement in ALS patients
  
   
• CNM-Au8 treated participants who demonstrated NAD/glutathione improvements demonstrated concordance in the same participants who were CNM-Au8 NfL Responders

SALT LAKE CITY, Aug. 06, 2024 (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 neurological diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced new CNM-Au8 biomarker and clinical efficacy data submitted to the FDA, including post hoc analyses from two independently conducted Phase 2 clinical trials of CNM-Au8 for the treatment of ALS. This new information supplements the original data previously discussed with FDA in late 2023 and is intended to guide the planned FDA Type C interaction expected to occur in the third quarter of 2024 to discuss an accelerated approval regulatory pathway.

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