Clene Nanomedicine Awarded Michael J. Fox Foundation Grant to Accelerate the Development of CNM-Au8 as a Treatment for Parkinson’s Disease

Clene Nanomedicine Awarded Michael J. Fox Foundation Grant to Accelerate the Development of CNM-Au8 as a Treatment for Parkinson’s Disease
  • Interim data from a Phase 2 target engagement study show that CNM-Au8 treatment was associated with improvements across key CNS bioenergetic metabolites in Parkinson’s disease patients
  • Initiation of a Phase 2 proof-of-concept trial in Parkinson’s disease patients expected in 2021

SALT LAKE CITY, March 01, 2021 (News) — Clene Inc. (NASDAQ: CLNN) (along with its subsidiaries, “Clene”) today announced that its wholly owned subsidiary Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company dedicated to revolutionizing the treatment of neurodegenerative disease using nanocatalysis, was awarded a new grant by The Michael J. Fox Foundation for Parkinson’s Research (MJFF) to accelerate the development of CNM-Au8, its lead neuroreparative nanocatalyst, as a treatment for Parkinson’s disease (PD).

“It is an honor to have the support of MJFF as we seek to develop CNM-Au8 as a novel treatment option for Parkinson’s disease,” said Rob Etherington, President and chief executive officer of Clene. “Interim target engagement data indicate that CNM-Au8 has a homeostatic effect on brain energetics in patients with PD that may allow it to ultimately slow or halt PD progression. We look forward to working with MJFF to build on these compelling data and accelerate the development of CNM-Au8 in PD.”

The MJFF funding will support preclinical studies in two complementary models of PD that will be led by Dr. Karen Ho, head of translational medicine at Clene, in collaboration with Prof. Michela Deleidi, Helmholtz Young Investigator at the German Center for Neurodegenerative Diseases (DZNE); and Dr. James Koprich, chief scientific officer of Atuka, Inc. The project will further evaluate the effects of CNM-Au8 on the survival and bioenergetic profiles of human PD patient dopaminergic neurons in the presence of PD-related neurotoxins and characterize the effects of CNM-Au8 on motor behaviors and neuronal survival in an animal model of PD, both of which will facilitate the advancement of CNM-Au8 into Phase 2 efficacy trials in PD patients.

Prof. Deleidi commented, “CNM-Au8 is a promising potential treatment for PD due to its nanocatalytic activity and ability to increase intracellular NAD+, decrease oxidative stress and activate genetic pathways that decrease misfolded protein accumulation in the context of neurodegenerative disease. I look forward to working with Clene to characterize CNM-Au8’s ability to improve neuronal survival through restoration of the bioenergetic pathways that are compromised in PD.”

PD is a progressive disorder of the central nervous system (CNS) that affects approximately seven million patients globally. There are no disease modifying treatment options available for PD patients, as current therapies only address symptoms of the disease. The potential of CNM-Au8 to address this unmet need is highlighted by interim Phase 2 data from the REPAIR-PD trial showing significant CNS target engagement of CNM-Au8 and improvements across key CNS bioenergetic metabolites in PD patients. These data are further supported by preclinical results suggesting that CNM-Au8 improves the survival of dopaminergic neurons and thereby may slow PD progression.

Clene expects to launch a Phase 2 trial evaluating the safety and efficacy of CNM-Au8 in PD patients by year-end. The Company also expects to report topline data from the REPAIR-PD target engagement study in the second half of 2021.

About REPAIR-PD

REPAIR-PD is a Phase 2, single-center, active only, sequential group, investigator blinded study to assess the metabolic effects, safety, pharmacokinetics and pharmacodynamics of CNM-Au8 in patients with Parkinson’s disease (PD) diagnosed within 3 years of screening. Investigators and participants are blinded to dose. Participants receive orally delivered CNM-Au8, the concentrated nanocrystalline gold (Au) suspension, daily each morning for 12 weeks. Participants undergo 31P-MRS brain imaging scans to semi-quantitatively measure bioenergetic metabolites at baseline, prior to and after administration of drug. The objective of this study is to demonstrate target engagement for CNM-Au8 on CNS biomarkers related to bioenergetics and neuronal metabolism in patients with PD. The study is taking place at the University of Texas Southwestern Medical Center with a team of internationally recognized experts in brain imaging and treatment of disorders of the CNS. Interim results from REPAIR-PD presented at the MSVirtual2020 Meeting show improvements across key CNS bioenergetic metabolites, including total nicotinamide adenine dinucleotide (NAD) levels, NAD+/NADH ratio (primary endpoint), and adenosine triphosphate (ATP) levels (secondary endpoint), indicating a homeostatic effect of CNM-Au8 on brain bioenergetics. Topline data are expected in 2H 2021. For more information see ClinicalTrials.gov Identifier: NCT03815916.

About CNM-Au8

Clene’s lead drug candidate, CNM-Au8, a bioenergetic nanocatalyst, is a stable, aqueous suspension of catalytically active gold (Au) nanocrystals. In a patented breakthrough, clean surfaced nanocrystalline CNM-Au8 drives critical cellular bioenergetic reactions in the brain to increase cellular energy, accelerate neurorepair, and improve neuroprotection. CNM-Au8 crosses the blood-brain barrier and is not associated with the toxicities related to synthetic gold compounds or synthetic nanoparticle chemistry. CNM-Au8 is currently being evaluated in a Phase 3 registration trial in amyotrophic lateral sclerosis (ALS), a Phase 2 trial for disease progression in patients with ALS, a Phase 2 trial for the treatment of chronic optic neuropathy in patients with stable relapsing multiple sclerosis (MS), and a Phase 2 brain target engagement study in Parkinson’s disease (PD) and MS. CNM-Au8 has demonstrated safety in Phase 1 studies in healthy volunteers and has shown both remyelination and neuroprotective effects in multiple preclinical (animal) models. Preclinical data, both published in peer-reviewed journals and presented at scientific congresses, demonstrate that treatment of neuronal cultures with CNM-Au8 improves survival of neurons, protects neurite networks, decreases intracellular levels of reactive oxygen species and improves mitochondrial capacity in response to cellular stresses induced by multiple disease-relevant neurotoxins. Oral treatment with CNM-Au8 improved functional behaviors in rodent models of ALS, MS, and PD versus vehicle (placebo).

About Clene

Clene, a clinical-stage biopharmaceutical company focused on neurodegenerative disease, has innovated a novel nanotechnology 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 drives critical cellular bioenergetic reactions in the CNS. CNM-Au8 increases cellular energy to accelerate neurorepair and improve neuroprotection. Currently, CNM-Au8 is being investigated for efficacy and safety in a Phase 3 registration trial for ALS and in Phase 2 trials for multiple sclerosis and Parkinson’s disease. Clene has also advanced into the clinic an aqueous solution of ionic zinc and silver for anti-viral and anti-microbial uses. The company is based in Salt Lake City, Utah with R&D and manufacturing operations in Maryland. For more information, please visit 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. Clene’s actual results may differ from its expectations, estimates and projections and consequently, 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,” “may,” “will,” “could,” “should,” “believes,” “predicts,” “potential,” “might” and “continues,” and similar expressions are intended 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 expected results. Factors that may cause such differences include Clene’s ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; Clene’s ability to achieve commercial success for its marketed products and drug candidates, if approved; Clene’s ability to obtain and maintain protection of intellectual property for its technology and drugs; Clene’s reliance on third parties to conduct drug development, manufacturing and other services; Clene’s limited operating history and its ability to obtain additional funding for operations and to complete the licensing or development and commercialization of its drug candidates; the impact of the COVID-19 pandemic on Clene’s clinical development, commercial and other operations, as well as those risks more fully discussed in the section entitled “Risk Factors” in Clene’s recently filed registration statement on Form S-4, as well as discussions of potential risks, uncertainties, and other important factors in Clene’s subsequent filings with the U.S. Securities and Exchange Commission. Clene undertakes no obligation to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based, subject to applicable law. All information in this press release is as of the date of this press release. The information contained in any website referenced herein is not, and shall not be deemed to be, part of or incorporated into this press release.

Media ContactAndrew MielachLifeSci Communications(646) 876-5868amielach@lifescicomms.com

Investor ContactBruce MackleLifeSci Advisors, LLC(929) 469-3859bmackle@lifesciadvisors.com

Source: Clene Inc.

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