ALS and MS Clinical Data from Clene’s CNM-Au8® Featured in Multiple Presentations at the 2023 American Academy of Neurology Annual Meeting

SALT LAKE CITY, April 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 diseases, announced that CNM-Au8^® results in multiple sclerosis (MS) and amyotrophic lateral sclerosis (ALS) were presented in plenary sessions at the 2023 (AAN) Annual Meeting, currently taking place in Boston. The MS platform presentation and ALS survival poster highlight the results from multiple clinical trials that demonstrated clinical benefit and safety of treatment with CNM-Au8, a cellular energetic nanocatalyst.

A poster presented by James Berry, MD, MPH, from Massachusetts General Hospital and Harvard University, entitled “Evidence for Survival Benefit in ALS with CNM-Au8 Treatment Across Three Study Populations,” highlighted the consistent survival results seen across broad ALS populations involving different stages of the disease. These findings support the advancement of clinical development of CNM-Au8 in a confirmatory Phase 3 study. Specific highlights of the poster included:

• Early ALS: Treatment with CNM-Au8 30mg demonstrated a statistically significant survival benefit of 60% and decreased risk of death through 120 weeks versus original placebo randomization.
• Mid-to-late stage ALS: Treatment with CNM-Au8 30mg was associated with a survival benefit of >90% decreased risk of death or permanent assisted ventilation through 24 weeks versus placebo.
• Real world experience ALS: Treatment with CNM-Au8 30mg was associated with median survival of greater than three years in an Expanded Access Program.
  
  

In addition, a plenary presentation by Michael Barnett, Ph.D., from the University of Sydney, highlighted results from the VISIONARY-MS study of CNM-Au8 that show improvements in clinical neurologic function and independent quantitative biomarkers of enhanced axonal integrity, measured by visual evoked potential (mf-VEP) amplitude and MRI diffusion tensor imaging (DTI) fractional anisotropy.

The primary and secondary endpoints in the VISIONARY-MS study mITT population demonstrated improved clinical outcomes, independent of an immunomodulatory effect. The prespecified exploratory MRI findings in the VISIONARY-MS study provide evidence of brain neuronal structural integrity assessed by DTI that demonstrated statistically significant results for key metrics of axonal and white matter integrity. Preservation of white matter integrity is associated with decreased cognitive and functional decline in MS patients.

CNM-Au8 was well-tolerated, and no significant safety findings were observed.

Rob Etherington, Clene’s President and CEO, said, “With this growing body of evidence, we are increasingly confident that CNM-Au8 has an effect across neurodegenerative diseases, such as ALS and MS, providing a potential treatment option with a novel and complementary mechanism of action for the patient community. Clene now awaits important new biomarker data from both the double-blind and open label periods of the HEALEY ALS Platform Trial. Within the next several months, we will understand the effects of CNM-Au8 on slowed clinical worsening and improved survival beyond the six-month double-blind period, up to 18 months of total treatment in the open-label extension. These data will help determine our regulatory filing strategy. In parallel, Clene plans to meet with the FDA in an end of Phase 2 meeting during the third quarter of 2023 to discuss the regulatory path forward for CNM-Au8 in ALS.”

The presentations are now available in the section of the Clene website.

About CNM-Au8^®, a gold nanocrystal suspension

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 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  or follow us on , , and .

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