Winrevair cuts clinical worsening risk with recent PAH diagnosis
Phase 3 trial shows 'significant and clinically meaningful' reduction
Adding Winrevair (sotatercept-csrk) to background treatment significantly reduces the risk of clinical worsening in people with a recent pulmonary arterial hypertension (PAH) diagnosis, according to results from a Phase 3 clinical trial.
The therapy led to “a statistically significant and clinically meaningful reduction in the risk of clinical worsening events when compared to placebo,” Merck, the company that sells Winrevair, said in a press release. The company didn’t provide details on the trial’s results.
“We look forward to presenting these data to the scientific community at a future medical meeting,” said Joerg Koglin, MD, PhD, senior vice president for global clinical development at Merck Research Laboratories.
The data come from a Phase 3 clinical trial called HYPERION (NCT04811092), which tested Winrevair against a placebo, given on top of double or triple combination therapy for PAH, in patients who were within a year of PAH diagnosis.
Earlier this year, Merck said it was ending the study early to allow all participants to transition into the open-label extension study, SOTERIA (NCT04796337), in which all will be treated with Winrevair.
Inclusion of those with recent PAH diagnosis bolsters ‘potential’
Winrevair, which is approved to treat adults with PAH in the U.S., Canada, and the European Union, is designed to block the activity of signaling molecules that drive abnormal growth of endothelial cells lining blood vessels in PAH. This abnormal growth narrows vessels and leads to high blood pressure.
The therapy was tested in two other Phase 3 trials, STELLAR (NCT04576988) and ZENITH (NCT04896008). Results from these trials have indicated that Winrevair can improve exercise capacity, boost heart health, and reduce mortality risk.
“To date, the strong clinical profile of WINREVAIR, a first-in-class activin signaling inhibitor, had been primarily established through previous studies in a prevalent patient population comprised of patients that were several years into their treatment journey,” Koglin said. “These positive results from HYPERION expand on the body of clinical evidence now including recently diagnosed adults, supporting the practice-changing potential of WINREVAIR in a broad spectrum of PAH patients, including those earlier in their treatment journey.”
The HYPERION study was designed to test if Winrevair was better than the placebo at reducing the risk of clinical worsening, a composite endpoint that included death due to any cause, lung transplant, hospitalization associated with PAH worsening lasting at least 24 hours, and exercise capacity deterioration.
The study “demonstrated that WINREVAIR on top of background therapy met its primary outcome measure of reduction in the time to clinical worsening events in adults who have been recently diagnosed with PAH,” said Vallerie McLaughlin, MD, an investigator on the trial and a professor at the University of Michigan.
“Patients often struggle for years to find a treatment plan that helps manage the disease, so it’s critical to provide new options earlier in the treatment journey,” McLaughlin said. “WINREVAIR has brought significant optimism to patients, their families and investigators and we thank all study participants for being part of this important study.”
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