New Data from Clene’s RESCUE-ALS Study to be Presented at 2022 ENCALS Meeting

• 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).