Clene Announces New CNM-Au8® Biomarker and Clinical Efficacy Data Submitted to FDA In Support of Treatment For ALS

About this update from Clene Inc.

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. 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 combined assessment of function and survival (CAFS): All-cause mortality (survival) : Improved survival of CNM-Au8 NfL Responders compared to propensity matched controls from the PRO-ACT database: HR: 0.504, 95% Wald CI: 0.28 – 0.904, covariate adjusted p = 0.022) Improved survival of CNM-Au8 NfL Responders compared to CNM-Au8 NfL non-responders : hazard ratio (HR): 0.350, 95% CI: 0.188 – 0.649; covariate adjusted, p = 0.0009 ALS Functional Improvement: the ALS Functional Rating Scale (ALSFRS-R) is an instrument for evaluating the functional status of patients with ALS and is used to monitor functional change in a patient over time. CNM-Au8 NfL Responders demonstrated: Significantly less decline in ALSFRS-R total score compared to CNM-Au8 NfL non-responders : p Significantly less decline in the respiratory subdomain score of the ALSFRS-R compared to CNM-Au8 NfL non-responders : p Improvements in the Combined Assessment of Function and Survival : CAFS ranks clinical outcomes based on survival time and change in the ALSFRS-R: CNM-Au8 NfL Responder demonstrated improvements compared to CNM-Au8 NfL non-responders starting at Week 48 (p

View stock analysis, news, and events for Clene Inc.