MSD has announced positive Phase III HYPERION trial results showing Winrevair (sotatercept-csrk) reduced clinical worsening events by 76% against placebo in recently diagnosed adults with pulmonary arterial hypertension (PAH).
The treatment was administered alongside background therapy to patients classified as WHO Group 1, functional class II or III, who were at intermediate or high risk of disease progression.
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Winrevair exhibited a hazard ratio of 0.24, as assessed by a composite endpoint encompassing all-cause mortality, non-planned PAH-related hospitalisation lasting 24 hours or more, atrial septostomy, lung transplantation, or deterioration of PAH.
Participants in the trial were within their first year of diagnosis, with a median duration of seven months and some as early as one-month, and more than 70% of them received double background therapy.
The Kaplan-Meier curves demonstrated an early and sustained separation, with a treatment benefit becoming evident within six weeks of randomisation.
The results indicated that 10.6% of subjects who received Winrevair experienced a minimum of one clinical worsening event, compared to 36.9% in the placebo group.
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By GlobalDataAdditionally, the treatment effect was observed to be consistent across the prespecified subgroups, which included subjects with idiopathic PAH, connective tissue diseases, recipients of double and triple background therapies, and subjects classified as intermediate or intermediate-low risk according to the REVEAL Lite 2 and COMPERA 2.0 risk assessment tools, respectively.
MSD Research Laboratories senior vice-president Dr Joerg Koglin said: “These positive results from Hyperion expand on the body of clinical evidence for Winrevair, now including PAH patients within their first year of diagnosis, including those earlier in their treatment journey.
“The totality of Winrevair data to date continues to reinforce our confidence in its practice-changing potential. We thank the study participants and investigators for their contributions to this important study.”
