Clene Inc CLNN presented new data from the RESCUE-ALS Phase 2 study of CNM-Au8, a catalytically active gold nanocrystal suspension for amyotrophic lateral sclerosis (ALS). Data were shared at the 4th Annual ALS ONE Research Symposium.
- New data presented included analyses of CNM-Au8's efficacy in limb and bulbar onset participants across critical endpoints of slowing ALS clinical worsening.
- Consistent clinical benefit was shown in both limb and bulbar onset participants for the pre-specified endpoint of ALS disease progression defined as death or the need for tracheostomy, non-invasive ventilation, or gastrostomy.
- Similarly, CNM-Au8 treated participants showed consistent clinical benefit in the proportion without a 6-point decline on the ALSFRS-R across both limb and bulbar onset participants in a post hoc analysis.
- Despite the small sample size of 45 subjects at 36 weeks, participants treated with CNM-Au8 had an improved average CAFS summated score of +4.4 compared to a -4.6 decline for the placebo group.
- The CAFS combines the change in ALS Functional score with participant survival time.
- Related: Clene's Amyotrophic Lateral Sclerosis Candidate Disappoints In Mid-Stage Study.
- Price Action: CLNN shares are up 5.45% at $6 during the market session on the last check Wednesday.
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