Clene’s (NASDAQ: CLNN) CNM-Au8(R) Affects Key Biomarkers, Long-term Survival in ALS Trials

August 23, 2024 08:27:39
  • Two Phase 2 independently conducted clinical trials showed significant improvement in key biomarkers among ALS patients who were administered CNM-Au8
  • Biomarker and efficacy data was submitted to the Food and Drug Administration for a granted Type C meeting request, with the company targeting an accelerated approval pathway
  • CEO Rob Etherington expressed optimism about CNM-Au8’s potential as a new ALS treatment, and voiced hope that ALS patients will benefit sooner rather than later
  • Clene recently presented its latest updates and findings at the Canaccord Genuity 44th Annual Growth Conference

Clene (NASDAQ: CLNN), a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, announced positive results of two independently conducted Phase 2 clinical trials, RESCUE-ALS and HEALEY ALS Platform Trials, of CNM-Au8 for the treatment of amyotrophic lateral sclerosis (“ALS”) (https://ibn.fm/ktu4u).

The new CNM-Au8 biomarker and clinical efficacy data was submitted to the FDA to supplement original data submitted in late 2023 and is intended to guide the granted FDA Type C interaction expected in the third quarter of 2024 to discuss an accelerated approval regulatory pathway, according to a…

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