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Clene Inc. (Nasdaq: CLNN) is a clinical-stage biopharmaceutical company leading the forefront of innovative treatments for neurodegenerative diseases. Utilizing their patented clean-surfaced nanotechnology (CSN), Clene has developed a groundbreaking electro-crystal-chemistry drug development platform, which produces stable, clean-surfaced nanocrystal suspensions. This cutting-edge technology allows for the creation of therapeutic nanoparticles designed to treat conditions such as amyotrophic lateral sclerosis (ALS), Parkinson’s disease, and multiple sclerosis (MS).
Headquartered in Salt Lake City, Utah, Clene operates with additional research and development facilities in Maryland. Their flagship product, CNM-Au8®, is a first-in-class investigational therapy that enhances mitochondrial health, thus protecting neuronal function. CNM-Au8® targets the central nervous system, facilitating improved cellular survival and function through mechanisms involving the NAD pathway and reduction of oxidative stress.
Recent significant achievements include:
- VISIONARY-MS Trial: Clene reported sustained improvement in vision and cognitive function in patients with stable relapsing MS during the long-term extension phase of the trial, demonstrating the potential of CNM-Au8® to improve neurological outcomes.
- ALS Expanded Access Program (EAP): Clene's EAP has shown promising survival benefits for individuals with advanced ALS, highlighting the robust efficacy and safety of CNM-Au8®.
- NIH Funding: Clene secured a substantial four-year grant from the National Institutes of Health to support an expanded access program for ALS, emphasizing the recognition and support from the broader medical and scientific community.
- Financial Position: As of the end of 2023, Clene reported $35 million in cash and equivalents, ensuring sufficient funding to advance their operations through 2024.
Clene continues to build on its promising clinical data, aiming to move CNM-Au8® into Phase 3 trials and potentially bring new hope to patients suffering from neurodegenerative diseases. For more information, visit Clene's website or follow them on social media platforms such as X (formerly Twitter) and LinkedIn.
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.
Clene Inc. (CLNN) reported significant clinical advancements for its treatment CNM-Au8 in two key trials targeting amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS). In the HEALEY ALS Platform Trial, CNM-Au8 showed a 74% reduced risk of ALS clinical worsening at six months, while the RESCUE-ALS Trial confirmed preserved physical function at 48 weeks. In MS, the VISIONARY-MS trial highlighted improvements in neurological function and brain structure. Financially, Clene ended 2022 with $23.3 million in cash, but reported a net loss of $29.9 million, up from $9.7 million in 2021. The company is focusing on advancing regulatory discussions with the FDA for both indications in 2023.
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