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Clene Inc. reports developments as a late clinical-stage biopharmaceutical company developing clean-surfaced nanotechnology therapeutics for neurodegenerative diseases. Through Clene Nanomedicine Inc., the company focuses on improving mitochondrial health and protecting neuronal function in amyotrophic lateral sclerosis, multiple sclerosis and Parkinson’s disease.
Recurring news centers on CNM-Au8®, an investigational nanocrystal suspension designed to target mitochondrial function and the NAD pathway while reducing oxidative stress. Company updates include ALS biomarker and expanded-access data, FDA meeting and regulatory communications, operating and financial results, registered direct financing activity, shareholder communications, voting matters and investor-conference presentations.
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Clene Inc. (NASDAQ: CLNN) announced significant findings at the 2023 AAN Annual Meeting regarding its treatment, CNM-Au8, for neurodegenerative diseases, specifically multiple sclerosis (MS) and amyotrophic lateral sclerosis (ALS). The data showcased a marked survival benefit in ALS patients, with early-stage treatment showing a 60% improvement and mid-to-late stage patients experiencing over 90% reduced death risk. In MS, the VISIONARY-MS study indicated enhancements in neurologic function and axonal integrity through various independent biomarkers. No notable safety concerns were observed. Clene is preparing for a Phase 3 study and anticipates critical new biomarker results from the HEALEY ALS Platform Trial, which will shape its regulatory strategy moving forward.
Clene Inc. (NASDAQ: CLNN) announced three presentations at the upcoming American Academy of Neurology Annual Meeting, scheduled for April 22-27, 2023, in Boston. The presentations will cover clinical trials demonstrating the efficacy and safety of their treatment CNM-Au8®. The studies include:
- VISIONARY-MS: A double-blind study on the efficacy of CNM-Au8 for relapsing multiple sclerosis, presented by Michael Barnett, Ph.D., on April 25.
- HEALEY ALS Trial: Results from the first four regimens of this platform trial, presented by Sabrina Paganoni, MD, Ph.D., also on April 25.
- Survival Benefit in ALS: Evidence for survival benefit with CNM-Au8 treatment, presented by James Berry, MD, MPH, on April 25.
These findings aim to support Clene's innovative approach in treating neurodegenerative diseases.
Clene, Inc. (Nasdaq: CLNN) has appointed Dr. Benjamin Greenberg as Head of Medical, enhancing its leadership in neurodegenerative disease treatment. Dr. Greenberg, an expert in central nervous system disorders, will support the Phase 3 clinical programs for the company’s lead asset, CNM-Au8, aimed at treating ALS and MS. His extensive background will be vital for the advancement of these therapies. Former Chief Medical Officer, Dr. Robert Glanzman, will continue in an advisory role. Clene is focused on addressing energy deficits in neurodegeneration, and recent developments indicate a commitment to ongoing clinical trials and potential partnerships.