Gilead drops resistant hypertension drug after Phase III failure
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Gilead Sciences would rather allocate resources to other promising pipeline opportunities after its once-daily endothelin receptor antagonist darusentan missed co-primary efficacy endpoints in a Phase III clinical trial, the company said Dec. 14. Gilead reported initial positive results in April from a separate Phase III study, but the data later revealed cardiovascular safety signals (1Health News Daily, May 29, 2009). Endothelin (ET-1) is an amino acid peptide produced by the vascular endothelium that is a powerful vasoconstrictor. Darusentan selectively blocks the endothelin type-A receptor, thus blocking ET-1 activation. But in the failed DAR-312 study, darusentan patients failed to achieve statistically significant differences in sitting systolic and diastolic blood pressure from baseline to week 14 compared to placebo. The drug, however, did demonstrate superiority in those measures compared to guanfacine, and it met other secondary endpoints, Gilead noted
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