Gilead’s Hypertension Drug Meets Primary Endpoints

Gilead Sciences’ Phase III DAR-311 (DORADO) study evaluating its endothelin receptor antagonist (ERA) darusentan for the treatment of resistant hypertension, met its co-primary efficacy endpoints. DORADO is one of two ongoing Phase III trials evaluating the safety, efficacy and tolerability of darusentan as an add-on treatment for resistant hypertension. The second study, DAR-312 (DORADO-AC), is expected to be complete by the end of this year.

In the DAR-311 study, reductions in mean trough sitting SBP from baseline of 8.6 mmHg, 16.5 mmHg, 18.1 mmHg and 18.1 mmHg were observed for the placebo, darusentan 50 mg, 100 mg and 300 mg groups, respectively, after 14 weeks of treatment. Reductions in mean trough sitting DBP from baseline of 5.3 mmHg, 10.1 mmHg, 9.9 mmHg and 10.7 mmHg were observed for the placebo, darusentan 50 mg, 100 mg and 300 mg groups, respectively, after 14 weeks of treatment. These results were statistically significant for all darusentan groups.

The most common adverse event was peripheral edema/fluid retention, which was reported in 17, 32, 36 and 29% of patients in the placebo, darusentan 50 mg, 100 mg and 300 mg groups, respectively. Full study results highlighting efficacy and safety will be submitted for presentation at a scientific meeting later this year.

“Failure to control blood pressure elevates the risk of a number of life-threatening cardiovascular conditions such as stroke, heart attack and heart failure, suggesting an unmet need for novel antihypertensive drugs with unique mechanisms of action that can be added to existing treatment regimens in patients with resistant hypertension. In this study, more than half of the patients treated with darusentan achieved goal blood pressure, as compared to approximately one quarter of patients receiving placebo,” said Norbert Bischofberger, Ph.D., Gilead’s executive vice president, R&D and chief scientific officer. “We look forward to presenting full results from this study and to completing our second Phase III study, which will further characterize darusentan’s safety and efficacy profile.”