Clene Nanomedicine Presents Blinded Interim Results from RES

Clene Nanomedicine Presents Blinded Interim Results from RESCUE-ALS Phase 2 Study at the 31st International Symposium on ALS/MND


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SALT LAKE CITY, Dec. 10, 2020 (GLOBE NEWSWIRE) -- Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company, today announced the presentation of blinded interim results from the Phase 2 RESCUE-ALS clinical trial investigating the effects of its lead clinical candidate, CNM-Au8, for the treatment of amyotrophic lateral sclerosis (ALS). CNM-Au8 is an aqueous suspension of clean-surfaced, faceted gold nanocrystals with catalytic activity that has been shown to enhance the metabolic energetic capacity of motor neurons while simultaneously reducing oxidative stress.
As of the data cutoff (October 27, 2020), the trial was fully enrolled with a preliminary blinded assessment of the study's primary endpoint, the motor neuron number index-4 [MUNIX(4)] score, showing that more than 40% of enrolled patients with completed week 12 data experienced improvements in motor neuron function assessed by MUNIX. When compared to baseline values, the average MUNIX(4) score of the overall trial population (including both active CNM-Au8 and placebo) experienced an absolute increase in mean MUNIX(4) values. This increase exceeded the expectations of the statistical modeling on which the study was based, which predicted a linear decline in average MUNIX(4) score from study onset (Neuwirth et al. JNNP 2015). These data, while blinded, suggest that CNM-Au8 may have neuro-reparative potential in ALS patients. Clene expects to report the complete, unblinded results from the RESCUE-ALS study in 2H 2021.

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