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
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:
Professor Steve Vucic, Ph.D., DSc, Northcott Chair of Neurology, The University of Sydney, and a co-inestigator of the RESCUE-ALS study, commented, “The totality of data generated from the CNM-Au8 ALS clinical program and the long-term patient benefits are highly encouraging. It is extraordinarily notable that a nine-month difference in treatment initiation with CNM-Au8 substantially preserved long-term function in patients originally receiving CNM-Au8 compared to patients originally receiving placebo during long-term follow-up. With its favorable tolerability profile and ability to be used alone or in combination with other ALS therapies, early treatment with CNM-Au8 may play an essential role in the treatment of ALS. We look forward to presenting these data at upcoming scientific congresses.”
“The open-label data at 48 weeks and through 120 weeks from randomization suggests that CNM-Au8 has the ability to meaningfully improve patient daily functional status over longer periods of time, together with sustained treatment effects on ALS disease progression and survival,” stated Professor Matthew Kiernan, Ph.D., DSc, Bushell Chair of Neurology, University of Sydney, and one of the trial’s clinical advisors. “It is exciting to see such long-term data not only reinforcing the potential of CNM-Au8 as a therapy for ALS but also confirming its excellent safety profile.”
These new data are summarized and posted at https://invest.clene.com/presentations/investor-presentation.
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