Clene Inc. (NASDAQ: CLNN), a late clinical-stage biopharmaceutical company, announced positive results from two Phase 2 clinical trials—RESCUE-ALS and HEALEY ALS Platform Trials—of its drug candidate CNM-Au8 for treating amyotrophic lateral sclerosis (ALS). The trials demonstrated significant improvements in key biomarkers among ALS patients treated with CNM-Au8.
The newly released biomarker and clinical efficacy data have been submitted to the Food and Drug Administration (FDA) to supplement earlier data from late 2023. This information is expected to guide a granted FDA Type C interaction in the third quarter of 2024 to discuss an accelerated approval regulatory pathway for CNM-Au8.
Rob Etherington, CEO of Clene, expressed optimism about the potential of CNM-Au8 as a novel treatment for ALS. Etherington voiced hope that ALS patients could benefit from this treatment sooner rather than later, highlighting the urgency of addressing this debilitating neurodegenerative disease.
Clene recently presented its latest updates and findings at the Canaccord Genuity 44th Annual Growth Conference, further showcasing the potential impact of CNM-Au8 on ALS treatment.
The significance of these clinical trial results and the potential for accelerated FDA approval cannot be overstated. If successful, CNM-Au8 could become a vital new option for ALS patients, offering hope for improved long-term survival and quality of life. The advancements in biomarker research and the pursuit of expedited regulatory pathways underscore the importance of innovative approaches in addressing unmet medical needs in neurodegenerative diseases.
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