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news.Darusentan demonstrated superiority in sitting SBP and DBP when compared to guanfacine at 14 weeks
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Gilead Sciences (Gilead) has reported that DAR-312 (DORADO-AC), a Phase III clinical trial evaluating darusentan did not achieve its co-primary efficacy endpoints of change from baseline to week 14 in trough sitting systolic blood pressure (SBP) and diastolic blood pressure (DBP). Darusentan is the company’s endothelin receptor antagonist (ERA) for the treatment of resistant hypertension.
Reportedly, DAR-312 is an international Phase III double-blind, placebo- and active-controlled, parallel group trial, in which 849 patients were randomised to receive darusentan (titrated to the optimal dose of 50, 100 or 300mg once daily), an active comparator (guanfacine 1mg once daily) or placebo.
The company said that the study was 95% powered to detect an 8mm Hg improvement in SBP and DBP between the darusentan and placebo groups. Reductions in mean trough sitting SBP and DBP from baseline were not statistically different between darusentan and placebo. The study result showed that darusentan did demonstrate superiority in sitting SBP and DBP when compared to guanfacine at 14 weeks; additionally the study met other secondary endpoints.
Darusentan is an oral, once-daily endothelin receptor antagonist (ERA) being investigated in clinical trials as an add-on oral therapy for patients with resistant hypertension. Darusentan selectively blocks the endothelin type-A (ETA) receptor, which if activated by endothelin-1 (ET-1), leads to vasoconstriction (narrowing of blood vessels) and cell proliferation.
Norbert Bischofberger, executive vice president of research and development and chief scientific officer at Gilead, said: “We are disappointed that darusentan did not achieve its primary endpoints in this study. As a result, we think it would be challenging to define an expedient path forward. We would likely be required to initiate another Phase III study and would rather allocate our resources to other promising research and development opportunities in our pipeline.”