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About Clene Inc. (Nasdaq: CLNN)
Clene Inc. is a late clinical-stage biopharmaceutical company dedicated to revolutionizing treatment options for neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS), and Parkinson’s disease. Headquartered in Salt Lake City, Utah, with research and development facilities in Maryland, Clene is at the forefront of leveraging nanotechnology to address critical unmet medical needs. The company’s patented Clean-Surface Nanocrystal (CSN) Technology enables the production of high-purity nanocrystals that enhance cellular energy metabolism and reduce oxidative stress, key contributors to neurodegeneration.
Core Technology and Innovation
Clene’s proprietary CSN platform represents a paradigm shift in pharmaceutical development, moving beyond traditional small-molecule drugs and biologics. By utilizing high-purity metallic nanocrystals, the technology targets mitochondrial function, the NAD pathway, and oxidative stress, enhancing the survival and functionality of central nervous system cells. This approach is exemplified by Clene’s lead candidate, CNM-Au8®, an oral suspension of gold nanocrystals designed to restore neuronal health and function.
Focus on Neurodegenerative Diseases
Clene is primarily focused on addressing neurodegenerative diseases with limited treatment options. Its flagship product, CNM-Au8®, is being developed for ALS, MS, and Parkinson’s disease. By improving mitochondrial health and reducing biomarkers like neurofilament light (NfL), CNM-Au8® has demonstrated potential in delaying disease progression and improving survival rates in clinical trials. Clene is also exploring the application of CNM-Au8® in rare diseases such as Rett Syndrome, further expanding its therapeutic scope.
Clinical Pipeline and Regulatory Progress
Clene’s clinical pipeline includes multiple Phase 2 and Phase 3 trials for CNM-Au8®. The company has garnered support from the National Institutes of Health (NIH) and other organizations to advance its research. Notably, Clene’s Expanded Access Programs (EAPs) provide real-world evidence of CNM-Au8®’s efficacy, particularly in ALS. These programs, combined with biomarker analyses and survival data, are integral to Clene’s pursuit of an accelerated approval pathway with the U.S. Food and Drug Administration (FDA).
Strategic Partnerships and Market Position
Clene collaborates with leading institutions, including Columbia University and Massachusetts General Hospital, to advance its clinical programs. The company recently partnered with APST Research GmbH to leverage one of the largest ALS biomarker datasets for regulatory submissions. By focusing on mitochondrial health and oxidative stress, Clene differentiates itself from competitors in the neurodegenerative disease space, such as Biogen and Amylyx Pharmaceuticals.
Commitment to Patients and Future Outlook
Clene’s mission is deeply rooted in improving patient outcomes. With over 800 participant-years of safety data and a robust clinical pipeline, the company is well-positioned to address the urgent needs of patients with neurodegenerative diseases. As Clene progresses toward regulatory milestones, its innovative approach to nanomedicine holds promise for transforming the treatment landscape.
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.
Clene Inc. (Nasdaq: CLNN) recently announced promising results from the HEALEY ALS Platform Trial, highlighting the efficacy of its treatment CNM-Au8 in delaying clinical progression in amyotrophic lateral sclerosis (ALS) patients. Key findings include a 74% reduced risk of overall clinical worsening (p=0.035) and a 98% reduction in the risk of death or permanent assisted ventilation (p=0.028). The treatment was well-tolerated, presenting no significant safety concerns. Clene plans to meet with the FDA to discuss these results and seek a regulatory pathway for CNM-Au8. A live webcast to review these findings is scheduled for today at 7:30 a.m. EST.
Clene Inc. (Nasdaq: CLNN) will host a live audio webcast on March 9, 2023, at 7:30 a.m. ET to discuss new clinical results from the Healey ALS Platform Trial regarding its investigational product CNM-Au8. This trial is a multi-center, double-blind, placebo-controlled study assessing the safety and efficacy of CNM-Au8 for treating ALS. The primary outcome focuses on changes in disease severity over 24 weeks, with secondary endpoints including respiratory function and overall survival. Archived webcasts will be available shortly after the event on the company’s website.
Clene Inc. (Nasdaq: CLNN) has announced its participation in significant events, including Roth's 35th Annual Healthcare Conference from March 12th-14th and Renmark Financial's Virtual Non-Deal Roadshow Series on March 7th and 22nd. At the Roth Conference, Clene will present on March 13 at 3:30 p.m. EDT, accessible via a webcast link. Additionally, the Renmark events will feature a live Q&A with CEO Rob Etherington and CFO Morgan Brown. Interested individuals can register for both events through provided links. Clene aims to advance treatments for neurodegenerative diseases, highlighting their innovative work in this domain.
Clene Inc. (Nasdaq: CLNN) announced positive results from the open-label extension (OLE) of its Phase 2 RESCUE-ALS trial for its treatment CNM-Au8® in patients with early amyotrophic lateral sclerosis (ALS). Key findings include a significant preservation of function measured by the ALSFRS-R with a p-value of 0.0159 over 48 weeks, and an overall 52% reduction in the risk of ALS clinical worsening across 120 weeks (HR: 0.478, p=0.0494). The treatment was well-tolerated without long-term safety concerns. These results suggest that early treatment with CNM-Au8 may improve patient functionality and slow disease progression in ALS.
Clene Inc. (Nasdaq: CLNN) reported updated results from the VISIONARY-MS Phase 2 trial at the ACTRIMS Forum 2023, demonstrating positive clinical outcomes for CNM-Au8 in treating stable relapsing MS patients. Key findings include:
- Visual Evoked Potential (VEP) results showed improved signaling from the eye to the brain.
- MRI analysis indicated significant improvements in brain structure integrity.
- CNM-Au8 treatment was well-tolerated with no major safety concerns.
These results support further investigation into CNM-Au8, addressing the significant unmet needs in MS therapeutics.
Clene Inc. (Nasdaq: CLNN) announced promising results from the VISIONARY-MS trial investigating CNM-Au8 in stable relapsing multiple sclerosis (MS) patients. Updated MRI results showed significant improvements in brain neuronal structural integrity and myelin health, independent of immunomodulatory effects. Among the 68 participants with advanced MRI data, key metrics indicated robust enhancements in white matter integrity. These findings support previous clinical results demonstrating global neurological function improvements. Clene plans to initiate a Phase 3 study to further explore CNM-Au8's potential in addressing unmet needs in MS treatment.
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