Clene Inc. Advances Neurodegenerative Disease Treatment with FDA-Backed Biomarker Analysis
TL;DR
Clene Inc.'s upcoming neurofilament biomarker analyses for CNM-Au8 in ALS could position it as a leader in neurodegenerative disease treatment, offering a competitive edge in biopharmaceutical innovation.
Clene Inc. will conduct neurofilament biomarker analyses in Q4 2025 to evaluate CNM-Au8's impact on neurodegeneration in ALS patients, following FDA feedback and a structured plan.
Clene Inc.'s research into CNM-Au8 for ALS and MS represents hope for improving lives by advancing treatments for debilitating neurodegenerative diseases.
Clene Inc. is exploring how CNM-Au8 affects neurodegeneration in ALS, a groundbreaking step towards understanding and treating complex neurological conditions.
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Clene Inc. (NASDAQ: CLNN), in collaboration with its subsidiary Clene Nanomedicine Inc., is gearing up to start neurofilament biomarker analyses for its leading drug candidate, CNM-Au8(R), in patients with amyotrophic lateral sclerosis (ALS). This initiative comes after receiving constructive feedback from the FDA during a recent Type C meeting. The analyses, planned for early Q4 2025, will evaluate changes in neurofilament light chain (NfL), a known indicator of neurodegeneration, among nearly 200 participants from the Expanded Access Program for CNM-Au8.
Dr. Benjamin Greenberg, Head of Medical at Clene, expressed optimism about the FDA's collaborative stance and their input on the NfL biomarker analysis plan. With additional FDA meetings on the horizon to discuss long-term ALS survival outcomes and End-of-Phase 2 results for multiple sclerosis (MS), Clene is making strides in its mission to offer groundbreaking treatments for those suffering from neurodegenerative diseases.
CNM-Au8(R) represents a pioneering approach to enhancing mitochondrial health and safeguarding neuronal function, with potential applications in treating ALS, Parkinson's disease, and MS. As a late clinical-stage biopharmaceutical entity, Clene is dedicated to addressing the urgent need for effective neurodegenerative disease therapies. The upcoming biomarker analyses underscore the company's commitment to advancing scientific understanding and therapeutic options for these challenging conditions.
For further details on Clene's innovative research and development efforts, visit https://www.Clene.com. Investors seeking the latest updates on Clene Inc. can find comprehensive information in the company's newsroom at https://ibn.fm/CLNN.
Curated from InvestorBrandNetwork (IBN)
