- New interim survival data from the ongoing RESCUE-ALS long-term open label extension (OLE) study demonstrate that early treatment (original randomization to active CNM-Au8) decreased risk of mortality by 62% when compared to either no treatment or delayed treatment (original randomization to placebo) (HR 0.38; p = 0.06)
- Updated interim survival data from this study also demonstrate that CNM-Au8 treatment of participants in the OLE reduced mortality risk by 64% when compared to the ENCALS predicted median survival (HR 0.36; p=0.008)
- New data from RESCUE-ALS will be presented that support CNM-Au8 effects on biomarkers of neurodegeneration and that show CNM-Au8-associated sustained long-term improvements in quality of life
- Preclinical data will be presented that support catalytically-active gold nanocrystals of CNM-Au8 as a promising new therapeutic strategy for the treatment of ALS
SALT LAKE CITY, June 01, 2022 (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 the presentation of new data from the company’s Phase 2 RESCUE-ALS study at the European Network to Cure ALS (ENCALS) Meeting 2022 taking place June 1-3 in Edinburgh, Scotland.
Clene will host at the conference five poster presentations about clinical and preclinical investigations of CNM-Au8, a new drug being developed as a potential disease-modifying treatment for the fatal neurodegenerative disease amyotrophic lateral sclerosis (ALS).
Poster 1: CNM-Au8 Gold Catalytic Activity Protects Neurons Against Degeneration and Death in Multiple in vitro Models of Amyotrophic Lateral Sclerosis
- Preclinical evidence for neuroprotection by CNM-Au8, using both human induced pluripotent stem cell and primary neural-glial models of ALS, indicate that catalytically-active gold nanocrystals of CNM-Au8 target energy metabolism by a novel mechanism holds promise as a new therapeutic strategy for the treatment of ALS.
Poster 2: Evidence for a Potential Survival Benefit in ALS with CNM-Au8 Treatment: Interim Results from the RESCUE-ALS Trial Long-Term Open Label Extension
- Important, newly released interim survival data from the long-term open label extension study demonstrate that early treatment (original randomization to active CNM-Au8) decreased risk of mortality by 62% when compared to delayed treatment (original randomization to placebo) (HR 0.38; p = 0.06); and decreased mortality risk by 64% when participant survival is compared to individual participant ENCALS predicted median survival (HR 0.36; p=0.008).
Poster 3: RESCUE-ALS Trial Results: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of CNM-Au8 to Slow Disease Progression in ALS
- The results from the RESCUE- ALS study provide evidence of safety and suggest efficacy of CNM-Au8 in patients with early ALS. The 36-week blinded period of RESCUE-ALS suggested efficacy benefits with CNM-Au8 treatment versus placebo: slowing ALS disease progression (p=0.0125), decreasing the proportion of participants with a 6-point decline in the ALS Functional Rating Scale Revised (ALSFRS-R) (p=0.035) and improving quality of life as measured by the ALS Specific Quality of Life (ALSSQOL-SF) questionnaire (p=0.018).
Poster 4: Interim ALS Specific Quality of Life Results from the Long-Term Open Label Extension of RESCUE-ALS, a Double-Blind, Placebo-Controlled Study of CNM-Au8 to Slow Disease Progression in ALS
- CNM-Au8 treatment resulted in improved quality of life assessed by the ALS Specific QOL short-form scale [ALSSQOL-SF), (p=0.018) during the 36-week double-blind period). Furthermore, during the OLE, subjects originally randomized to CNM-Au8 continued to maintain stable ALSSQOL-SF scores through 84 weeks or more of treatment. Ex-placebo participants who transitioned to the CNM-Au8 treatment during the long-term OLE demonstrated similar stability.
Poster 5: Preliminary Biomarker Findings from the RESCUE-ALS Double-Blind, Placebo-Controlled Study of CNM-Au8 to Slow Disease Progression in ALS
- CNM-Au8 treated participants in the RESCUE-ALS study demonstrated decreased levels of markers of neurodegeneration, specifically plasma ubiquitin C-terminal hydrolase L1 and urinary neurotrophin receptor p75 extracellular domain normalized to creatine levels, compared to placebo over the 36-week double-blind period.
“These emerging data highlight the significantly reduced risk of mortality following early and sustained treatment with CNM-Au8.,” said Rob Etherington, President and CEO of Clene. “The magnitude of the effect, more than 60% reduction in risk versus delayed treatment, provides hope for people with ALS and their caregivers. Based on these emerging survival data, the RESCUE-ALS open-label has been extended indefinitely, and we are excited to understand how CNM-Au8 treatment may continue to keep people with ALS alive and with stable quality of life.”
Dr. Robert Glanzman, Clene’s Chief Medical Officer, said, “As we continue to perform preclinical experiments in collaboration with academic partners and analyze the enriching dataset from RESCUE-ALS, the data consistently highlight CNM-Au8 as an emerging therapeutic option for people with this devastating disease. We look forward to the next major data readout from the HEALEY ALS platform trial that is expected in the third quarter.”
The posters will be available on-demand via the conference portal and on the Events and Presentations section of the Clene website beginning at 7 a.m. EDT today.
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 https://clene.com or follow us on Twitter, LinkedIn, and Facebook.
Forward-Looking Statements
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