Overview
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companies_clene["Clene Nanomedicine"]
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companies_clene_0["History and Evolution"]
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companies_clene_1["Pipeline Overview"]
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companies_clene_2["Pipeline Visualization"]
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companies_clene_3["Key Programs"]
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companies_clene_4["CNM-Au8 - Amyotrophic Lateral Sclerosis"]
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companies_clene_5["CNM-Au8 - Multiple Sclerosis"]
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...Overview
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Clene Inc. is a clinical-stage biopharmaceutical company headquartered in Salt Lake City, Utah, dedicated to revolutionizing the treatment of neurodegenerative diseases by restoring and protecting neuronal health and function["@clene2024"]. The company's proprietary nanotherapeutic platform develops clean-surface nanocrystal (CSN™) therapeutics that target cellular energy impairments common to many neurodegenerative diseases["@clene2024a"]. Clene's lead candidate, CNM-Au8®, is a gold nanocrystal suspension in development for [amyotrophic lateral sclerosis (ALS)/diseases/amyotrophic-lateral-sclerosis], [multiple sclerosis (MS)/diseases/multiple-sclerosis], and [Parkinson's disease (PD)/diseases/parkinsons-disease][@clene2024a].
History and Evolution
Clene was founded with a focus on leveraging nanotechnology to address the fundamental cellular energy deficits that underlie neurodegenerative conditions. The company's founding approach was based on the understanding that impaired cellular energy metabolism is a common thread in diseases like [ALS](/diseases/amyotrophic-lateral-sclerosis), [MS](/diseases/multiple-sclerosis), and [Parkinson's](/diseases/parkinsons-disease)[@clene2024].
The company's lead candidate, CNM-Au8®, has demonstrated promise in preclinical studies. In SOD1 G93A mouse models of ALS, Au8 improved motor coordination, establishing the biological rationale for clinical development in human ALS patients[@clene2024a]. Clene has partnered with leading academic institutions and patient advocacy organizations to advance its clinical programs.
Pipeline Overview
Clene's pipeline focuses on nanotherapeutic candidates for neurodegenerative diseases with high unmet medical needs.
Pipeline Visualization
Key Programs
CNM-Au8® - Amyotrophic Lateral Sclerosis
CNM-Au8® is Clene's lead nanotherapeutic candidate, a gold nanocrystal suspension designed to target cellular energy impairment in [ALS](/diseases/amyotrophic-lateral-sclerosis). The compound has been evaluated in multiple clinical trials including the HEALEY-ALS Platform Trial (NCT04414345) and RESCUE-ALS (NCT04098406)[@clene2024a].
CNM-Au8® - Multiple Sclerosis
In [multiple sclerosis](/diseases/multiple-sclerosis), CNM-Au8® has shown potential for enhancing remyelination in preclinical cuprizone studies. The REPAIR-MS trial (NCT03993171) evaluated the candidate in MS patients[@clene2024a].
CNM-Au8® - Parkinson's Disease
CNM-Au8® is being developed for [Parkinson's disease](/diseases/parkinsons-disease), addressing the fundamental [mitochondrial dysfunction](/mechanisms/mitochondrial-dysfunction) that is a core pathological mechanism in PD. The REPAIR-PD trial (NCT03815916) investigated the candidate's effects in PD patients[@clene2024a].
Mechanism in Parkinson's Disease
The nanotherapeutic approach targets multiple mitochondrial mechanisms central to PD pathogenesis:
- Complex I Support: CNM-Au8 has demonstrated ability to improve mitochondrial complex I activity, which is specifically deficient in PD [dopaminergic neurons](/cell-types/dopaminergic-neurons)[@cnmau2024]
- Oxidative Stress Catalysis: Unlike simple antioxidants, the nanocrystals catalyze redox reactions to reduce harmful ROS while preserving beneficial cellular signaling
- Alpha-Synuclein Modulation: Emerging research suggests potential effects on [protein aggregation](/mechanisms/protein-aggregation) pathways relevant to PD
- Neuronal Energy Support: Improved ATP production in high-energy-demand [dopaminergic neurons](/cell-types/dopaminergic-neurons)
- Neuroinflammation Modulation: Effects on [microglial activation](/cell-types/microglia) that may protect neurons
Clinical Development
The REPAIR-PD study evaluated whether nanocatalytic therapeutics could address the fundamental energy deficits in Parkinson's disease. Given the strong preclinical rationale and central role of mitochondrial dysfunction in PD, CNM-Au8 represents a differentiated approach compared to traditional antioxidant therapies[@clene2024a][@cnmau2024].
CNM-ZnAg
Beyond CNS indications, Clene is developing CNM-ZnAg, a zinc-silver ionic solution with antiviral and antimicrobial properties[@clene2024a].
Clean-Surface Nanocrystal (CSN™) Technology
Clene's proprietary CSN platform enables the creation of clean-surfaced, catalytically-active nanocrystals for therapeutic use. These nanocrystals are designed to address cellular energy impairments by supporting mitochondrial function and reducing oxidative stress[@clene2024][@clene2024a].
Mechanism of Action
The nanocrystals work at the cellular level to improve energy metabolism in neurons and supporting cells. By enhancing cellular energetics, CNM-Au8® may protect neurons from degeneration and support remyelination in diseases like MS[@clene2024a].
Clinical Evidence
ALS Clinical Trials
Multiple clinical trials have evaluated CNM-Au8® in ALS patients, including the HEALEY-ALS Platform Trial, a landmark adaptive trial designed to accelerate ALS therapeutic development[@clene2024a].
MS Clinical Trials
The REPAIR-MS and VISIONARY-MS trials have evaluated CNM-Au8® in patients with multiple sclerosis, examining both safety and potential remyelination effects[@clene2024a].
Leadership
Clene is led by President & CEO Rob Etherington, who brought nearly 30 years of pharmaceutical experience from Actelion and Parke-Davis. Mark Mortenson serves as Chief Science Officer and is the co-inventor of CSN technology with over 30 U.S. patents. Dr. Benjamin Greenberg, Professor of Neurology at UT Southwestern, leads medical affairs[@clene2024].
Partnerships
Clene collaborates with leading academic medical centers and patient advocacy organizations to advance its clinical programs. The company participates in the HEALEY-ALS Platform Trial, a collaborative effort across multiple ALS research centers[@clene2024a].
See Also
- [Mitochondrial Dysfunction in Parkinson's Disease](/mechanisms/mitochondrial-dysfunction)
- [Amyotrophic Lateral Sclerosis](/diseases/amyotrophic-lateral-sclerosis)
- [Multiple Sclerosis](/diseases/multiple-sclerosis)
- [Parkinson's Disease](/diseases/parkinsons-disease)
- [Gold Nanoparticles in Neurology](/entities/gold-nanoparticles)
- [ALS Therapeutics](/treatments/als-therapeutics)
- [Alpha-Synuclein](/proteins/alpha-synuclein)
- [Dopaminergic Neurons](/cell-types/dopaminergic-neurons)
- [Microglia](/cell-types/microglia)
- [Protein Aggregation](/mechanisms/protein-aggregation)
External Links
- [Clene Nanomedicine Official Website](https://clene.com/)
- [ClinicalTrials.gov - Clene Studies](https://clinicaltrials.gov/)
- [ALS Association](https://www.als.org/)
- [National Multiple Sclerosis Society](https://nationalmssociety.org/)
- [Parkinson's Foundation](https://www.parkinson.org/)
References
Clene Inc, Company Website (2024)
Clene Inc, Pipeline (2024)
CNM-Au8 in Parkinson's disease, ClinicalTrials.gov NCT03815916 (2024)