Clene ( NASDAQ: CLNN ) said its medicine CNM-Au8 significantly improved survival of patients with amyotrophic lateral sclerosis (ALS) patients, compared to placebo in the long-term open-label extension part of a trial called RESCUE-ALS.
In the study , patients were randomized to receive either 30-mg CNM-Au8 or placebo daily for 36 weeks, followed by an open-label period that extended treatment up to 130 weeks from randomization.
The company said survival data were obtained for 43 out of 45 patients, with a cut-off as of July 5.
Clene said there were were five deaths in the group originally randomized to CNM-Au8 and 14 deaths in the group originally randomized to receive placebo.
Median survival from randomization for those on CNM-Au8 was undefined due to insufficient mortality events, while median survival for the placebo group was 23.1 months, according to the company's July 14 press release.
Clene added that an analysis showed a significant survival benefit for partients initially randomized to CNM-Au8, compared to those initially randomized to placebo, resulting in a 70% decreased risk of death.
The company noted that there were no significant safety findings.
ALS is a progressive nervous system disease affecting the nerve cells in the brain and spinal cord, causing loss of muscle control.
CLNN +12.50% to $3.24 premarket July 14
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Clene stock rises 13% as drug cuts risk of death by 70% in ALS patients in trial