Clene Inc. is a clinical-stage biopharmaceutical company focused on developing innovative treatments for neurodegenerative diseases through its proprietary nanotherapeutic platform. This platform utilizes a patented electro-crystal-chemistry process to create clean-surfaced, catalytically-active nanocrystals that target cellular energy impairments, which are prevalent in conditions such as Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), and Parkinson’s Disease (PD). The lead product, CNM-Au8®, is a gold nanocrystal suspension designed to enhance cellular energy production by catalyzing the conversion of NAD+ to ATP, thereby addressing the energy deficits that contribute to neuronal dysfunction and degeneration.

In addition to CNM-Au8®, Clene is advancing other nanotherapeutics, including CNM-ZnAg, a zinc-silver ionic solution with antiviral and antimicrobial properties, and CNM-AgZn17, a topical gel aimed at treating infectious diseases and promoting wound healing. Another candidate, CNM-PtAu7, combines gold and platinum nanotherapeutics and has shown promise in preliminary studies against various tumor cell lines. Clene's commitment to addressing high unmet medical needs through its innovative nanotechnology positions it as a leader in the evolving landscape of drug development for neurodegenerative and other serious health conditions.

United States

Clene Inc., a clinical-stage biopharmaceutical company, focuses on the development of various therapeutics for neurodegenerative diseases. The company has a nanotechnology drug platform for the development of orally administered neurotherapeutic drugs. Its lead drug is CNM-Au8, which is being studied in various clinical trials, including a Phase 2 study for the treatment of stable multiple sclerosis; a Phase 2 biomarker study in Parkinson’s; and Phase 2 and Phase 3 trials to investigate the potential for disease modification for neurodegenerative diseases. The company’s products also include CNM-AgZn17, a topical gel polymer suspension of silver and zinc ions that is being developed for the treatment of infectious diseases and to accelerate wound healing; and NM-PtAu7, a gold-platinum CSN therapeutic. Clene Inc. is based in Salt Lake City, Utah.

Central Nervous System (CNS)

Immune System Diseases

Clene Inc

Amyotrophic lateral sclerosis

Clene’s lead &nbsp;drug candidate, CNM-Au8, a bioenergetic nanocatalyst, is a stable, &nbsp;aqueous suspension of catalytically active gold (Au) nanocrystals. In a &nbsp;patented breakthrough, clean surfaced nanocrystalline CNM-Au8 drives &nbsp;critical cellular bioenergetic reactions in the brain to increase &nbsp;cellular energy, accelerate neurorepair, and improve neuroprotection. &nbsp;CNM-Au8 crosses the blood-brain barrier and is not associated with the &nbsp;toxicities related to synthetic gold compounds or nanoparticles &nbsp;manufactured via synthetic chemistry. CNM-Au8 is currently being &nbsp;evaluated in a Phase 3 registration trial in amyotrophic lateral &nbsp;sclerosis (ALS), a Phase 2 trial examining disease progression via a &nbsp;novel electromyography technique in patients with early ALS, a Phase 2 &nbsp;trial for the treatment of chronic optic neuropathy in patients with &nbsp;stable relapsing multiple sclerosis (MS), and Phase 2 brain target &nbsp;engagement studies in patients with Parkinson’s disease (PD) and MS. &nbsp;CNM-Au8 has demonstrated safety in Phase 1 studies in healthy volunteers &nbsp;and has shown both remyelination and neuroprotective effects in &nbsp;multiple preclinical (animal) models. Preclinical data, both published &nbsp;in peer-reviewed journals and presented at scientific congresses, &nbsp;demonstrate that treatment of neuronal cultures with CNM-Au8 improves &nbsp;survival of neurons, protects neurite networks, decreases intracellular &nbsp;levels of reactive oxygen species and improves mitochondrial capacity in &nbsp;response to cellular stresses induced by multiple disease-relevant &nbsp;neurotoxins. Oral treatment with CNM-Au8 improved functional behaviors &nbsp;in rodent models of ALS, MS, and PD versus vehicle (placebo).
<a href="https://invest.clene.com/press-releases/Press-Releases/news-details/2021/Clene-Reports-Full-Year-2020-Operating-and-Financial-Highlights/default.aspx">Source</a>

CNM-Au8

Multiple sclerosis

COVID-19

CNM-ZnAg &nbsp;is a proprietary zinc-silver ionic solution that has demonstrated both &nbsp;antiviral and antibacterial properties in addition to boosting immune &nbsp;response. Participants in the Phase 2 study must have presented with two &nbsp;or more symptoms of acute COVID-19 infection within 96 hours prior to &nbsp;baseline visit, self-reported as moderate or severe. SARS-CoV-2 &nbsp;infection must be confirmed by polymerase chain reaction (PCR) testing &nbsp;within 96 hours prior to baseline visit. Patients enrolled in the study &nbsp;will be randomized 1:1:2 to receive either a low or high dose of ZnAg or &nbsp;placebo in a double-blind fashion, in addition to standard supportive &nbsp;care.
<a href="https://invest.clene.com/press-releases/Press-Releases/news-details/2021/Clene-Nanomedicine-Initiates-Phase-2-Study-of-CNM-ZnAg-for-Patients-with-COVID-19/default.aspx">source</a>

Clene Inc

Company Details