Merck's Hypertension Drug Cuts Clinical Worsening Risk In Over 70% Of Patients On Double Background Therapy

Merck & Co., Inc. MRK on Monday announced positive topline results from the Phase 3 HYPERION study evaluating Winrevair (sotatercept-csrk) versus placebo (both in combination with background therapy) in recently diagnosed adults with pulmonary arterial hypertension (PAH) functional class (FC) II or III at intermediate or high risk of disease progression.

HYPERION met its primary endpoint of time to clinical worsening (TTCW) as measured by a composite endpoint of all-cause death, the need for non-planned PAH-related hospitalization > 24 hours, atrial septostomy, lung transplantation, or PAH deterioration.

In HYPERION, Winrevair added on top of background therapy (72.2% of patients on double therapy) within 12 months after initial diagnosis of PAH demonstrated a statistically significant and clinically meaningful reduction in the risk of clinical worsening events compared to placebo.

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HYPERION is the third Phase 3 study of Winrevair to demonstrate significant efficacy in adults with PAH.

The first was the STELLAR study previously presented at ACC.23, followed by the ZENITH study presented at ACC.25.

In contrast to HYPERION, these previous studies included a patient population in which the majority of participants were on triple therapy. The safety profile of Winrevair was generally consistent with that observed in previous studies.

As announced in January, HYPERION was stopped early and moved to final analysis based on the positive results from the interim analysis of the Phase 3 ZENITH trial and a review of the totality of data from the WINREVAIR clinical program to date.

All patients were offered the opportunity to receive Winrevair through the SOTERIA open-label extension study.

Winrevair is currently approved in more than 45 countries based on the results from the STELLAR study.

Price Action: MRK stock is trading higher by 0.44% to $79.41 at last check Monday.

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