Merck announced that it has ended its phase 3 Hyperion trial early due to overwhelming efficacy from the primary endpoint and from previous trials. The latest trial was evaluating Winrevair (sotatercept-csrk) versus placebo for treatment in adults with newly diagnosed pulmonary arterial hypertension (PAH) functional class two or three.
The decision to end the study prior to its scheduled completion was based on the positive results from the interim analysis of the Zenith trial as well as a review of the totality of data from the Winrevair clinical program to date. Merck, along with the program’s external steering committee, discussed the decision with the U.S. Food and Drug Administration (FDA) and decided that stopping the study would give participants the opportunity to access Winrevair.
“PAH is a progressive and debilitating disease with a high incidence of morbidity and mortality, and we look forward to continuing the evaluate these patients and any potential impact to the treatment landscape as a result of these data,” said Vallerie McLaughlin, MD, the Kim A. Eagle, MD, Endowed Professor of Cardiovascular Medicine and director of the pulmonary hypertension program at the University of Michigan in Ann Arbor.
According to the press release, Merck is allowing participants from the Hyperion trial to continue treatment in the phase 3 Soteria study, an ongoing, open-label extension study that is evaluating the long-term safety, efficacy and tolerability of Winrevair with background therapy.
Winrevair is currently FDA-approved in the United States, as well as 38 other countries, based on results from the phase 3 Stellar trial.
