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Clene Announces Publication of Phase 2 CNM-Au8® Clinical Data for the Treatment of ALS in LANCET’s eClinicalMedicine
Peer-reviewed publication includes data from the CNM-Au8 Phase 2 RESCUE-ALS trial and its open-label-extension, up to 120 weeks of patient follow-up SALT LAKE
About this update from Clene Inc.
[{"type":"text","content":"Peer-reviewed publication includes data from the CNM-Au8 Phase 2 RESCUE-ALS trial and its open-label-extension, up to 120 weeks of patient follow-up SALT LAKE CITY, June 26, 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 that The Lancet’s journal eClinicalMedicine has published combined detailed analyses of the Phase 2 RESCUE-ALS study and its open-label extension trial. The article can be accessed via the following link: https://authors.elsevier.com/sd/article/S2589537023002134. “Results from RESCUE-ALS study were important because they provided the first insights about the clinical benefits of CNM-Au8 in ALS patients and the duration of treatment required to detect them,” said Professor Steve Vucic, PhD, DSc, Northcott Chair of Neurology, The University of Sydney, and a co-investigator of the RESCUE-ALS study. “The treatment effect demonstrated a clear survival signal associated with CNM-Au8 treatment and evidence for delayed clinical worsening morbidity events such as tracheostomy and initiation of feeding tube during the double-blind placebo-controlled period. Additional functional benefits such as decreased worsening of ALSFRS-R scores are emerging later through the long-term open-label extension.” “These results corroborate the mechanism that energetic support of neurons may protect CNS health and slow neurodegenerative disease progression and are a basis for continued clinical evaluation of this promising drug candidate,” said Professor Matthew Kiernan, PhD, DSc, Bushell Chair of Neurology, University of Sydney, and one of the trial’s clinical advisors. “In addition, our trial explored the utility of a novel primary endpoint, MUNIX, which has advanced the state of ALS research and will help future studies of other investigational ALS treatments.” “We are pleased that CNM-Au8 results in RESCUE-ALS were concordant with the larger Phase 2b HEALEY ALS Platform Trial,” said Ben Greenberg, MD FAAN, Head of Medical at Clene. “We plan to report long-term follow-up data from this program later this year and meet with the FDA in the third quarter to identify next steps for our ALS program.” About RESCUE-...