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The international award will fund a preclinical study of CNM-Au8 nanocatalysis for improving human health and lifespan in the context of aging and Alzheimer’s disease
Clene expects the disease indications for CNM-Au8 to expand beyond amyotrophic lateral sclerosis, Parkinson’s disease and multiple sclerosis
SALT LAKE CITY, May 17, 2021 (GLOBE NEWSWIRE) – Clene Inc. (NASDAQ: CLNN) (together with its subsidiary “Clene”) announced today that its wholly-owned subsidiary Clene Nanomedicine, Inc., a biopharmaceutical, is in the clinical stage The company, which is dedicated to the treatment of neurodegenerative diseases using bioenergetic nanocatalysis, received the Healthy Longevity Catalyst Award from the US National Academy of Medicine (NAM) for the preclinical development of CNM-Au8, a bioenergetic nanocatalyst, for the treatment of neuronal age-related diseases Accelerate Deficits and Alzheimer’s Disease. The global competition for healthy longevity was launched by NAM in 2019 to “stimulate innovation from the world’s greatest minds” and to support healthy longevity around the world.
NAM and its seven global employees have received over 1,500 entries and ultimately awarded more than $ 7.7 million in the opening round of the Catalyst Awards, part of the broader global competition for healthy longevity. Clene received a NAM Catalyst Award based on the novelty and innovation of CNM-Au8 as a therapeutic approach to diseases related to neuronal aging. In addition to receiving an award, the winners will also attend the first annual Innovator Summit for Healthy Longevity in September 2021 to share their work with policy makers, researchers and other innovators from around the world.
“We are very pleased to receive this award from the US National Academy of Medicine in recognition of the potential of our therapeutic nanocatalyst, CNM-Au8, to contribute to healthy longevity,” said Rob Etherington, President and Chief Executive Officer. “We at Clene have made it our business to revolutionize the treatment of neurodegenerative diseases with bioenergetic nanocatalysts. NAM’s support provides an opportunity to potentially expand the target indications of CNM-Au8 to include additional neurodegenerative diseases of old age, including Alzheimer’s disease. CNM-Au8 is currently being investigated in four Phase 2 and one Phase 3 clinical trials for the treatment of amyotrophic lateral sclerosis, Parkinson’s disease and multiple sclerosis. “
The NAM funding supports a joint preclinical effort demonstrating the unique bioenergetic effects of CNM-Au8 on deficits related to aging and Alzheimer’s disease. The study is led by Dr. Karen Ho, Head of Translational Medicine at Clene, headed in collaboration with Assistant Professor Jerome Mertens from the University of Innsbruck (Austria), whose expertise lies in reprogramming human cells into directly induced neurons that are epigenetically and metabolically preserved as markers of aging. The work aims to identify key mechanisms by which CNM-Au8 can influence age-related neurodegenerative diseases, including Alzheimer’s.
Professor Mertens from the Laboratory for Neural Aging, Institute for Molecular Biology, University of Innsbruck, Austria, stated: “I am very excited about this project with Clene and I am grateful for the support from the National Academy of Medicine. It is difficult to find strategies to disrupt age-related neurodegeneration. However, we are very optimistic that a lot of information will be gained by testing CNM-Au8 in the context of its actual target cells, which are older human neurons. “
About Alzheimer’s DiseaseAlzheimer’s disease is the most common form of dementia. An estimated 5.8 million Americans will be living with Alzheimer’s disease in 2020. It is a progressive neurodegenerative disease that affects memory, cognition, and language. Age is the most well-known risk factor for the disease. There is currently no known treatment that can stop or stop the progression of this disease.
About CNM-Au8
Clene’s lead drug candidate, CNM-Au8, a bioenergetic nanocatalyst, is a stable aqueous suspension of catalytically active gold (Au) nanocrystals. As a result of a patented breakthrough in manufacturing, the self-assembled, clean-surface nanocrystals of CNM-Au8 lead to critical cellular bioenergetic reactions in the brain that increase cell energy, improve neurorepair, and improve neuroprotective protection. CNM-Au8 crosses the blood brain barrier and is not associated with the toxicities associated with synthetic gold compounds or nanoparticles made by alternative methods. CNM-Au8 is currently being evaluated in a phase 3 registration study in amyotrophic lateral sclerosis (ALS), a phase 2 study to investigate the course of the disease using a novel electromyography technique in patients with early ALS, a phase 2 study to treat chronic disease Optic neuropathy in patients with stable relapsing multiple sclerosis (MS) and phase 2 studies of brain targeting in patients with Parkinson’s disease (PD) and MS. CNM-Au8 has shown safety in phase 1 studies in healthy volunteers and has shown both remyelination and neuroprotective effects in several preclinical (animal) models. Preclinical data, both published in journals and presented at scientific congresses, show that treatment of neuronal cultures with CNM-Au8 improves neuron survival, protects neurite networks, lowers intracellular levels of reactive oxygen species, and improves mitochondrial capacity in response to cells Stress from numerous disease-related neurotoxins. Oral treatment with CNM-Au8 improved functional behavior in rodent models of ALS, MS and PD compared to the vehicle (placebo).
About Clene
Clene, a clinical-stage biopharmaceutical company focused on neurodegenerative diseases, is a leader in the use of nanotechnology to treat bioenergetic failure that underlies many neurological diseases. Clene has innovated a novel nanotherapeutic platform to create a new class of drugs – bioenergetic nanocatalysts. Clene’s lead drug candidate, CNM-Au8, is a concentrated nanocrystalline gold (Au) suspension that triggers critical cellular bioenergetic responses in the CNS. CNM-Au8 increases cellular energy to accelerate neurorepair and improve neuroprotection. CNM-Au8 is currently being investigated for efficacy and safety in a phase 3 registration study for ALS and in phase 2 studies for multiple sclerosis and Parkinson’s disease. Clene has also brought an aqueous solution of ionic zinc and silver to the clinic for antiviral and antimicrobial purposes. The company is based in Salt Lake City, Utah, and has research and development and manufacturing facilities in Maryland. More information is available at www.clene.com.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Actual results by Clene could differ from expectations, estimates and projections. Therefore, you should not rely on these forward-looking statements as predictions of future events. Words such as “expect”, “estimate”, “project”, “budget”, “forecast”, “anticipate”, “intend”, “plan”, “can”, “will”, “could”, “should” ” believes, “predicts,” “potentially,” “could,” and “continues,” and similar expressions are used to identify such forward-looking statements. These forward-looking statements involve significant known and unknown risks and uncertainties, many of which are beyond Clene’s control and could cause actual results to differ materially and adversely from anticipated results. One of the factors that can cause such differences is Clene’s ability to demonstrate the effectiveness and safety of its drug candidates. the clinical results for its drug candidates that may not support further development or marketing approval; Actions by regulatory authorities that may affect the initiation, timing and progress of clinical trials and marketing authorization; Clene’s ability to achieve commercial success for its marketed products and drug candidates, if approved; Clene’s ability to obtain and maintain intellectual property protection for his technology and drugs; Clene relies on third parties for drug development, manufacturing and other services; Clene’s limited operating history and ability to obtain additional funding for operations and complete licensing or development and commercialization of his drug candidates; the impact of the COVID-19 pandemic on the clinical development, commercial and otherwise operations of Clene; and the risks discussed in more detail in the “Risk Factors” section of Clene’s Annual Report filed on Form 10K, as well as a discussion of potential risks, uncertainties and other important factors in Clene’s subsequent filings with the US Securities and Exchange Commission. Clene undertakes no obligation to publicly release any updates or revisions to any forward-looking statements to reflect changes in its expectations or changes in events, conditions or circumstances on which such statements are based, subject to applicable law. All information in this press release is as of the date of this press release. The information on websites referred to here does not form part of this press release and is not to be considered a part of this press release.
Media contactGwendolyn SchankerLifeSci Communications (269) 921-3607gschanker@lifescicomms.com
Investor contactBruce MackleLifeSci Advisors, LLC (929) 469-3859bmackle@lifesciadvisors.com
Source: Clene Inc.
Source: Clene Inc.
