Keryx Biopharmaceuticals has reported that following a Drug Safety and Monitoring Committee review of the Sun-Macro Phase IV trial of Sulonex, the company has decided to terminate the study and cease further development of Sulonex.
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The company previously said that the trial had been suspended pending an interim analysis, following which the company would make a decision regarding whether the trial ought to be continued or terminated.
Based on a review of the available proteinuria data, Sulonex did not appear to be different than placebo. The study was not terminated by the Drug Safety and Monitoring Committee for a safety problem or safety signal.
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