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Clene Announces New CNM-Au8® Biomarker and Clinical Efficacy Data Submitted to FDA In Support of Treatment For ALS
CNM-Au8 treated participants in the HEALEY ALS Platform Trial with substantial neurofilament light (NfL) declines (CNM-Au8 NfL Responders) demonstrated
About this update from Clene Inc.
[{"type":"text","content":"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-respondersIndependent 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 controlsNicotinamide 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 patientsCNM-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. The level of neurofilament light (NfL) in plasma is considered an important biomarker of ALS disease progression and mortality risk. CNM-Au8 NfL Responders, defined as those who had consistent and sustained NfL reductions, comprising nearly half of all CNM-Au8 treated patients, demonstrated a 28% mean reduction in NfL levels compared to baseline, while NfL levels continued to increase in CMN-Au8 NfL non-responders (all doses; geometric mean ratio (GMR) difference at week 76 post-baseline: 0.57, 95% CI: 0.50 – 0.64, p New analyses of the CNM-Au8 NfL Responders demonstrated efficacy in all-cause mortality, functional, and co...