Clene Inc. Advances Neurodegenerative Disease Treatment with FDA-Backed Biomarker Analysis

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.