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New Data Show CNM-Au8® Preserved ALS Patient Function and Slowed Disease Progression in the Open-Label Extension of the Phase 2 RESCUE-ALS Trial
Significant preservation of function (ALSFRS-R) from randomization to 48 weeks (p=0.0159)Significant preservation of function (ALSFRS-R) during the long-term
About this update from Clene Inc.
[{"type":"text","content":"Significant preservation of function (ALSFRS-R) from randomization to 48 weeks (p=0.0159)Significant preservation of function (ALSFRS-R) during the long-term open-label extension (OLE) week 24 to 120 weeks from randomization (p=0.0057) Significantly reduced risk of ALS clinical worsening by 52% over 120 weeks (HR: 0.478, p=0.0494)CNM-Au8 treatment was well-tolerated without long term safety concerns SALT LAKE CITY, March 06, 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, today announced new results showing preserved ALS patient functional score (ALSFRS-R) and delayed time to clinical worsening from the most recent 12-month data cut of the open-label extension (OLE) of the Phase 2 RESCUE ALS trial in people with early amyotrophic lateral sclerosis (ALS) treated with CNM-Au8®. “Clene is pleased to report that CNM-Au8 preserved physical function in the long-term open-label portion of the Phase 2 RESCUE-ALS trial when given over 48-weeks as measured by the ALSFRS-R, a clinical assessment measuring activities such as walking, speaking, breathing, feeding, and dressing independently,” said Rob Etherington, President and CEO of Clene. “Together with improved survival and slowing ALS clinical worsening, these functional changes are meaningful to people living with ALS.” Study participants in RESCUE-ALS were randomized 1:1 to receive 30 mg of CNM-Au8 or placebo daily for 36 weeks during the double-blind portion of the study, followed by an OLE period that extended treatment indefinitely. The trial randomized 45 participants (n=23 active treatment, n=22 placebo). Thirty-six participants continued into the OLE, including 20 of 21 eligible participants (95%) originally randomized to CNM-Au8, and 16 of 19 eligible (84%) participants originally randomized to placebo. The OLE analyses compared participants originally randomized to placebo who experienced a nine-month delay in treatment initiation with CNM-Au8 to participants treated daily with CNM-Au8 from randomization. New Findings from RESCUE-ALS OLE through 120 Weeks: The current data cut represents a 12-month minimum follow-up for OLE participants from the last-patient last-vi...