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[1]. The company's proprietary nanotherapeutic platform develops clean-surface nanocrystal (CSN™) therapeutics that target cellular energy impairments common to many neurodegenerative diseases[2]. 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][2:1].
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, MS, and Parkinson's[1:1].
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[2:2]. Clene has partnered with leading academic institutions and patient advocacy organizations to advance its clinical programs.
Clene's pipeline focuses on nanotherapeutic candidates for neurodegenerative diseases with high unmet medical needs.
CNM-Au8® is Clene's lead nanotherapeutic candidate, a gold nanocrystal suspension designed to target cellular energy impairment in ALS. The compound has been evaluated in multiple clinical trials including the HEALEY-ALS Platform Trial (NCT04414345) and RESCUE-ALS (NCT04098406)[2:3].
In 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[2:4].
CNM-Au8® is being developed for Parkinson's disease, addressing the fundamental mitochondrial dysfunction that is a core pathological mechanism in PD. The REPAIR-PD trial (NCT03815916) investigated the candidate's effects in PD patients[2:5].
The nanotherapeutic approach targets multiple mitochondrial mechanisms central to PD pathogenesis:
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[2:6][3:1].
Beyond CNS indications, Clene is developing CNM-ZnAg, a zinc-silver ionic solution with antiviral and antimicrobial properties[2:7].
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[1:2][2:8].
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[2:9].
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[2:10].
The REPAIR-MS and VISIONARY-MS trials have evaluated CNM-Au8® in patients with multiple sclerosis, examining both safety and potential remyelination effects[2:11].
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[1:3].
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[2:12].