Although the main outcome measure of the trial was not met (“Changes in DUX4-driven gene expression, which were included in the trial as an experimental biomarker endpoint, could not be demonstrated”), there are positive conclusions to draw from the trial. Based on these results, the Company plans to meet with health authorities, including the U.S. Food and Drug Administration (FDA), in the second half of 2021 to determine the regulatory path for losmapimod in FSHD.
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