Clene (CLNN) and its wholly owned subsidiary Clene Nanomedicine announced completion of the FDA-recommended biomarker analyses for CNM-Au8 in people living with ALS. The results demonstrate statistically significant reductions in both neurofilament light, NfL, and glial fibrillary acidic protein, GFAP, and provide compelling evidence linking biomarker decline to improved survival. New Biomarker Analyses: Statistically significant decrease in NfL levels compared to matched ALS controls across the full analysis set in the NIH-EAP; Additional disease-relevant biomarker effects on GFAP were identified with statistically significant declines observed during the double-blind period in the HEALEY ALS Platform Trial; Among placebo-treated participants who transitioned to CNM-Au8 in the HEALEY ALS Platform Trial OLE, NfL trajectories generally showed decline or stabilization compared to increases observed during the double-blind period; NfL and GFAP biomarker decline is associated with improved survival.
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