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Re: H2R post# 1555

Monday, 10/10/2022 3:13:36 PM

Monday, October 10, 2022 3:13:36 PM

Post# of 1569
SA article / Ph III ALS - DMC recommended Continuation

Same news packaged in a different way on SA:

Cytokinetics (NASDAQ:CYTK) said a data monitoring committee (DMC) recommended the continuation of a phase 3 trial of reldesemtiv to treat amyotrophic lateral sclerosis (ALS), after reviewing unblinded data.

The DMC had assemble to conduct the first planned interim analysis of the ongoing phase 3 study, dubbed COURAGE-ALS, which assessed for the potential of futility.

The first interim analysis was done 12 weeks after about one-third or more of the intended number of patients were randomized to participate in the study.

The study is expected to enroll ~555 patients with ALS who will receive either 300 mg of reldesemtiv or matching placebo dosed orally twice daily for 24 weeks, followed by a 24-week period in which all patients will receive 300 mg of reldesemtiv twice daily.

The main efficacy goal is change from baseline to 24 weeks in the ALS Functional Rating Scale – Revised (ALSFRS-R).

ALS is a progressive nervous system disorder affecting nerve cells in the brain and spinal cord, leading to loss of muscle control.
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