Johnson & Johnson’s $230 million blood pressure bet has hit the mark in the phase 3 clinical trial. According to reports, the treatment “significantly” reduced blood pressure in patients with resistant hypertension.
According to reports, Johnson & Johnson chose the development of the dual endothelin receptor antagonist aprocitentan in 2017, paid $230 million upfront, and agreed to a royalty rate that runs from 20 percent to 35 percent to secure global rights to aprocitentan.
Reportedly, the deal came months after the delivery of phase 2 data from Idorsia, which was created earlier in 2017 as part of Johnson & Johnson’s $30 billion takeovers of Actelion.
According to reports, the phase 3 results will shape whether aprocitentan can capture that blockbuster opportunity. The multipart clinical trial began with a four-week treatment period and it included 730 patients who had a systolic blood pressure of 140 mmHg or more despite receiving the recommended antihypertensive therapy during the screening stage of the study.
During the second phase of the study, the participants received 25 mg of aprocitentan for 32 weeks. Meanwhile, Idorsia said that the blood pressure reductions were maintained, and subjects who switched from placebo experienced the same blood pressure reduction as seen in the first part of the trial.
Furthermore, the third part of the study re-randomized 614 patients to receive 25 mg of aprocitentan or placebo for 12 weeks. After four weeks, the blood pressure in the placebo arm increased significantly compared to the treatment group, causing the study to hit that secondary endpoint with a p-value of less than 0.0001.
The company revealed that in the phase 3 clinical trial, approximately 30 percent of patients developed edema or fluid retention at one-time point during the entire study. Meanwhile, more than 95 percent of the cases were mild or moderate.
