J&J, Idorsia build out pivotal dataset for their $230M hypertension drug, showing a maintained response

J&J and Idorsia presented new Phase III data for their hypertension drug Tuesday morning.

The trial found that aprocitentan, the drug in question, reduced blood pressure by a statistically significant margin and maintained its effect for up to 48 weeks, the companies said. Researchers were testing aprocitentan in patients whose high blood pressure is tough to control and in combination with standard background therapies.

Janssen, J&J’s R&D unit, unveiled the pivotal results with Idorsia at the American Heart Association’s 2022 conference. They also published the data in The Lancet.

In the study, 730 patients were randomized about equally into three groups, taking one of two doses of aprocitentan or placebo for four weeks. After this period, all patients received the high dose of 25 mg for 32 weeks. Finally, patients were once again randomized at the end of this period to receive either the high dose or placebo for 12 weeks.

Of the original 730 patients, 577 made it through all three parts of the trial. The study’s primary endpoint was the change from baseline in blood pressure after four weeks (part 1), which it achieved at both dose levels. The low dose achieved a numerically higher reduction in blood pressure compared to placebo, but both were statistically significant.

Martine Clozel

Specifically, the low, 12.5 mg dose reduced blood pressure by -15.3 mmHg, compared to -11.5 for placebo, good for a p-value of p=0.0042. The high dose reduced blood pressure by -15.2 mmHg, clocking in at a p-value of p=0.0046. The study also hit the secondary measure of maintaining the effect after another 32 weeks (part 2).

The primary endpoint results were initially released in a topline data update back in May, but Tuesday was the first time the companies showed the effect could be maintained during the second part of the study.

J&J paid Idorsia $230 million back in 2017 to snag commercialization rights to the drug on the back of its $30 billion buyout of Actelion, which was run by the husband-and-wife team of CEO Jean-Paul Clozel and CSO Martine Clozel.

For Idorsia, the data come after the biotech won its first FDA approval back in January for Quviviq, an insomnia drug that some analysts expect will surpass $1 billion in sales. But it hasn’t all been roses — in May, Idorsia dumped a binge-eating drug candidate after it failed a Phase II test.

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