Clene Nanomedicine Presents Updated Long-Term Survival Data from RESCUE-ALS Participants at 2022 AANEM Scientific Conference
SALT LAKE CITY, Sept. 21, 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 diseases, today announced presentation of updated survival results from the Phase 2 RESCUE-ALS trial open-label extension (OLE) at the 2022 American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM) Clinical & Scientific Conference, taking place September 21-24 in Nashville, Tennessee.
The poster titled, “Evidence for a Potential Survival Benefit in Amyotrophic Lateral Sclerosis with CNM-Au8 Treatment: Interim Results from the RESCUE-ALS trial Long-Term Open Label Extension,” provides ongoing evidence supporting the clinical benefits of Clene’s lead drug candidate, CNM-Au8®, a catalytically active gold nanocrystal suspension that holds promise as a disease-modifying therapy for amyotrophic lateral sclerosis (ALS). Specifically, the poster evaluated the survival benefit associated with long-term CNM-Au8 treatment. Updated interim analyses of all-cause mortality with up to 137 weeks of follow-up from randomization comparing participants originally randomized to CNM-Au8 to participants originally randomized to placebo demonstrated a significant survival benefit with CNM-Au8 treatment, resulting in approximately a 70% decreased risk of death (HR = 0.29, p=0.01). Sensitivity analyses of observed survival compared to predicted median survival derived from the published ENCALS prediction model based on each participant’s baseline study characteristics, with a data cutoff of August 31, 2022, also demonstrated a significant survival benefit with CNM-Au8 treatment (HR = 0.36, p=0.003). CNM-Au8 treatment was well-tolerated, and there were no significant safety findings reported during the OLE.
“These clinical and survival data from RESCUE-ALS contribute to the growing body of evidence supporting the potential for CNM-Au8 as a disease-modifying therapy for amyotrophic lateral sclerosis (ALS),” said Robert Glanzman, MD, FAAN, Clene’s Chief Medical Officer.
Rob Etherington, Clene’s CEO, added, “The impressive ALS survival benefits seen with CNM-Au8 treatment corroborate our thesis – energetic support of neurons may protect CNS health and slow neurodegenerative disease progression. We look forward to upcoming results from the HEALEY ALS Platform Trial and advancing CNM-Au8 development in ALS and other neurodegenerative diseases, including multiple sclerosis and Parkinson’s.”
The primary blinded comparative period was followed by an open-label extension (OLE) in which all participants received 30 mg of CNM-Au8 once-daily, with 90% (36/45 patients) entering the OLE. The primary endpoint was not significant, driven by limited MUNIX decline in bulbar-onset participants. However, in a prespecified analyses of limb-onset participants who demonstrated the expected decline in MUNIX scores, there was a strong trend for reducing MUNIX scores (p=0.074). There was a significant reduction in ALS disease progression evident in CNM-Au8 treated participants at week 36 (p=0.0125), and the risk of experiencing significant (= 6-point) decline in ALSFRSR was significantly reduced in the CNM-Au8 treated patients (p=0.035). Furthermore, CNMAu8 treated participants demonstrated improved quality of life on the ALSSQOL-SF (p=0.018). Importantly, there were no significant CNM-Au8 related adverse effects reported.
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Source: Clene Inc.