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Hypertension News

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Early Winrevair Trial End To Allow All Patients To Start Active Treatment

Merck announced that its Phase 3 clinical trial HYPERION, which had been testing Winrevair (sotatercept-csrk) in people with recently diagnosed pulmonary arterial hypertension (PAH), will be ended early — a move that will allow all study participants, including those who had been assigned to receive a placebo, to be given active treatment with the PAH therapy.

The participants in HYPERION (NCT04811092) can now all choose to be treated with Winrevair as part of the open-label extension study SOTERIA (NCT04796337), according to the developer.

The decision to end the trial early was based on new positive data from another Phase 3 trial of Winrevair — early results that Merck said made continuing HYPERION unnecessary, and also not helpful for its participants.

"Based on the strong, positive interim efficacy data from the ZENITH trial, as well as the totality of available Winrevair data, we concluded that it would not be ethical to continue the HYPERION study," Eliav Barr, MD, chief medical officer, senior vice president and head of global clinical development at Merck Research Laboratories, said in a company press release.

Barr expressed the company's thanks to "the dedicated community of patients who participated in these studies" and noted that Merck is "pleased to offer the option of receiving Winrevair through the Phase 3 SOTERIA … study." SOTERIA is ongoing at 189 locations worldwide, and is expected to enroll an estimated 700 participants.

All of the HYPERION participants are in functional class 2 or 3, as set by the World Health Organization, and have an intermediate or high risk of disease progression, the company noted.

For some in HYPERION, it will now be active treatment instead of placebo

Merck's decision to pull the plug on HYPERION followed positive data from the ZENITH clinical trial (NCT04896008). That study, launched in 2021, was testing Winrevair against a placebo, on top of background therapy, in people with PAH.

According to the company, results from ZENITH showed that Winrevair significantly reduced mortality risk among PAH patients at high risk of dying. That trial was also stopped early to allow all patients to access the drug.

After reviewing data from ZENITH and other studies of Winrevair, Merck and the trial's steering committee decided that continuing HYPERION would not be ethically justifiable, given that some patients would be getting the placebo instead of the active treatment.

"After closely reviewing the robust efficacy data across a broad spectrum of patients evaluated in the Winrevair clinical development program, the steering committee has unanimously concluded that the HYPERION study, evaluating Winrevair versus [a] placebo on top of background therapy, has lost clinical equipoise and should be stopped early," said Vallerie McLaughlin, MD, an investigator on both the HYPERION and ZENITH studies and a professor at the University of Michigan in Ann Arbor. Equipoise means that investigators have true uncertainty about a therapy's merits.

In PAH, the cells that line the inside of blood vessels, called endothelial cells, grow abnormally, narrowing vessels and leading to abnormally high blood pressure in the vessels that carry blood through the lungs. Winrevair, given every three weeks by subcutaneous or under-the-skin injection, works to block molecular signals that drive the abnormal growth of endothelial cells.

Winrevair is approved to treat adults with PAH in the U.S. And Canada, and in the European Union.

After closely reviewing the robust efficacy data across a broad spectrum of patients evaluated in the Winrevair clinical development program, the steering committee has unanimously concluded that the HYPERION study … has lost clinical equipoise and should be stopped early.

Merck noted that it has discussed the decision to stop HYPERION early with the U.S. Food and Drug Administration. The company said it plans to present details on the results from the study later this year.

Noting that PAH is "a progressive and debilitating disease with a high incidence of morbidity and mortality," McLaughlin said investigators "look forward to continuing to evaluate these patients and any potential impact to the treatment landscape as a result of these data."

Another Trial Of Winrevair Stopped Early Due To Positive Efficacy

The HYPERION study was evaluating Winrevair in recently diagnosed adults with pulmonary arterial hypertension.

Merck has stopped a study of Winrevair (sotatercept-csrk) early because of positive results seen an interim analysis of a separate trial.

Merck officials made the decision to stop the HYPERION study prior to its scheduled completion. The phase 3 HYPERION study evaluating recently diagnosed adults with pulmonary arterial hypertension (PAH) was stopped because an interim analysis of the ZENITH trial and a review of the totality of data from Winrevair the clinical program to date that showed positive efficacy results, Merck officials said in a news release.

Winrevair is currently approved in the United States and 38 countries to treat pulmonary arterial hypertension and to reduce the risk of clinical worsening events. In preclinical models, Winrevai induced cellular changes that were associated with thinner vessel walls, partial reversal of right ventricular remodeling, and improved hemodynamics. The FDA approved Winrevair in March 2024, and it has a list price of $14,420 per vial.

Pulmonary arterial hypertension is a rare, progressive and life-threatening disease in which blood vessels in the lungs narrow, causing strain on the heart. About 40,000 people in the United States are living with PAH. The five-year mortality rate is about 43%.

Vallerie McLaughlin, M.D.

"PAH is a progressive and debilitating disease with a high incidence of morbidity and mortality, and we look forward to continuing to evaluate these patients and any potential impact to the treatment landscape as a result of these data," Vallerie McLaughlin, M.D., said in the news release. She is the Kim A Eagle M.D. Endowed Professor of Cardiovascular Medicine and Director, Pulmonary Hypertension Program at the University of Michigan in Ann Arbor.

The phase 3 HYPERION study was evaluating Winrevair compared with placebo (both in combination with background therapy) in recently diagnosed adults with pulmonary arterial hypertension. The study enrolled about 300 patients, and the primary composite outcome measure is time to clinical worsening, as measured by first confirmed morbidity or mortality event. Secondary outcome measures include improvement of six-minute walk distance and improvement and maintenance or achievement of N-terminal pro-B-type natriuretic peptide. Company officials said in the release that findings from the HYPERION study will be available later this year and presented at a future medical congress.

Related: Winrevair Advanced PAH Trial Stopped Early Due to 'Overwhelming' Efficacy

The ZENITH study was evaluating Winrevair in advance patients when added to maximum tolerated background PAH therapy on time to first event of all-cause death, lung transplantation, or PAH worsening related hospitalization of ≥24 hours. The study enrolled 172 participants. ZENITH was also stopped early because it had shown a statistically significant and clinically meaningful reduction in morbidity and mortality risk compared with placebo.

Participants in the HYPERION trial will have the opportunity to be part of the open-label, long-term extension study, SOTERIA, which is evaluating the long-term safety, tolerability and efficacy of Winrevair when added to background therapy to treat patients with PAH.

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