Merck halts Winrevair HYPERION trial early on positive results

30 January 2025

US pharma giant Merck & Co (NYSE: MRK) today revealed an early stop to the Phase III HYPERION study evaluating Winrevair (sotatercept-csrk) versus placebo (both in combination with background therapy) in recently diagnosed adults with pulmonary arterial hypertension (PAH, WHO Group 1) functional class (FC) II or III at intermediate or high risk of disease progression.

The decision to stop the HYPERION study prior to its scheduled completion was based on the positive results from the interim analysis of the ZENITH trial and a review of the totality of data from the Winrevair clinical program to date. The program’s external steering committee and Merck made this decision in light of these data, which will enable all study participants to have the opportunity to access Winrevair.

Merck said it discussed this decision with the US Food and Drug Administration (FDA) and has informed HYPERION study investigators.

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