Clene Awarded Grant From National Multiple Sclerosis Society to Advance Development of CNM-Au8® in Non-Active Progressive Multiple Sclerosis

SALT LAKE CITY, May 25, 2023 (GLOBE NEWSWIRE) — Clene, Inc. (Nasdaq: CLNN), along with its subsidiaries “Clene” and its wholly owned subsidiary Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative disease, today announced that Clene has received a grant from the National Multiple Sclerosis Society (NMSS) via the organization’s Fast Forward Program, a competitive, expert-reviewed funding opportunity to support commercial organizations that are developing new therapies for the treatment of multiple sclerosis (MS).

The specific focus of this program is to identify and fund the development of promising new therapies that promote nervous system repair and regeneration in MS. Clene’s lead drug candidate, CNM-Au8®, a catalytically active gold nanocrystal suspension, has been shown to elicit robust remyelination and repair in multiple in vitro and animal models by enhancing energy metabolism in central nervous system cells.

The one-year grant will fund Cohort 2 of REPAIR-MS, a Phase 2 clinical study investigating target engagement of CNM-Au8 in patients with non-active progressive MS. Using non-invasive brain imaging, the study will enroll up to 15 individuals with primary progressive or non-active secondary progressive MS and determine the effects of 12 weeks of CNM-Au8 daily oral dosing on critical brain energy metabolites that have been shown to be compromised in individuals with MS. The study will be carried out at the University of Texas Southwestern Medical School under lead investigator Dr. Peter Sguigna and imaging expert Dr. Jimin Ren. Benjamin Greenberg, M.D., a Professor and Vice Chair of Clinical & Translational Research at UTSW, is not affiliated with this project.

“We are thrilled to be the recipient of a prestigious Fast Forward Grant and eager to advance our understanding of CNM-Au8in the treatment of non-active progressive MS,” said Karen Ho, Ph.D., VP of Translational Medicine, of Clene Nanomedicine. “Our previous REPAIR-PD and REPAIR-MS (Cohort 1) studies demonstrated target engagement with CNM-Au8 treatment in both patients with Parkinson’s Disease and in patients with relapsing remitting multiple sclerosis (RRMS). Positive results from this study will extend the demonstration of brain target engagement of CNM-Au8 to non-active progressive MS as well.”

“There is a significant unmet need for treatments for the progressive loss of function that takes place in all forms of MS,” added Dr. Benjamin Greenberg, Head of Medicine at Clene. “The results from the newly funded study will also build on the results of the randomized, double-blind, placebo-controlled Phase 2 VISIONARY-MS trial in relapsing MS. VISIONARY-MS demonstrated that treatment with CNM-Au8 improves vision and clinical scores across multiple physiological domains as measured by the MS Functional Composite scale, which combines scores for low contrast vision, working memory, fine motor skills, gross motor skills and balance. We embrace the opportunity offered to us by the National MS Society to continue to develop CNM-Au8 as a unique disease-modifying treatment that addresses energetic deficits associated with neurodegeneration.”

“Building on previous work from REPAIR-MS to extend evidence of target engagement for CNM-Au8 exemplifies our effort to provide leverage to de-risk clinical development,” said Mark Allegretta, Ph.D., Vice President, Research, National MS Society. “We are eager to see the brain biomarker results from CNM-Au8 treatment in people living with non-active progressive MS from this study”.

About CNM-Au8®
CNM-Au8 is an oral suspension of gold nanocrystals developed to restore neuronal health and function by increasing energy production and utilization. The catalytically active nanocrystals of CNM-Au8 drive critical cellular energy producing reactions that enable neuroprotection and remyelination by increasing neuronal and glial resilience to disease-relevant stressors. CNM-Au8® is a federally registered trademark of Clene Nanomedicine, Inc.

About the REPAIR Clinical Trial Program
REPAIR-MS and REPAIR-PD are Phase 2 single-center, active-only, sequential group studies examining the brain metabolic effects, safety, pharmacokinetics, and pharmacodynamics of CNM-Au8 in patients who have been diagnosed with MS within 15 years of screening or in patients with PD who have been diagnosed within three years of screening. The objective of these studies is to demonstrate target engagement for CNM-Au8 on CNS biomarkers related to energetics and neuronal membrane stability in patients with MS and PD. Investigators and participants are blinded to dose. Participants,13 patients in REPAIR-PD and 11 patients in REPAIR-MS (all study participants with repeat imaging data), received orally delivered CNM-Au8 daily each morning for 12 weeks. Participants underwent 31P-MRS brain imaging scans to semi-quantitatively measure central nervous system (CNS) energetic metabolites at baseline, prior to administration of drug, and at the end-of-study following at least 12 weeks of exposure to CNM-Au8. The studies are 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. For more information see ClinicalTrials.gov Identifiers: NCT03993171 and NCT03815916.

About Clene
Clene is a clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative disease by targeting energetic failure, an underlying cause of many neurological diseases. 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 or follow us on Twitter, LinkedIn and Facebook.

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