US-based pharmaceutical company MSD has reported that the Phase III ZENITH trial of WINREVAIR (sotatercept-csrk) for pulmonary arterial hypertension (PAH) met its primary endpoint.
The double-blind, placebo-controlled trial evaluated WINREVAIR’s efficacy in treating 172 adult individuals with PAH functional class III or IV at high mortality risk.
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Subjects were randomised to receive either WINREVAIR alongside their standard PAH therapy or a placebo with their usual treatment.
The primary outcome of time to first morbidity or mortality event was achieved at interim analysis.
It required subjects to have a Registry to Evaluate Early and Long-Term PAH Disease Management (REVEAL) Lite 2.0 risk score of nine or higher, indicating a high risk of mortality.
The occurrence of adverse events and serious adverse events was similar across both treatment and placebo groups in preliminary assessment.
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By GlobalDataBased on these results, an independent data monitoring committee has recommended the early termination of the ZENITH study.
MSD Research Laboratories global clinical development head, senior vice-president and chief medical officer Dr Eliav Barr said: “PAH is a serious, progressive disease with a high incidence of morbidity and mortality.
“These findings are impressive, set a high evidentiary bar for studies of future candidates developed for the treatment of PAH and support the potential of WINREVAIR to be practice-changing in the management of PAH.”
Earlier this month, MSD submitted an application for approval of WINREVAIR in Japan based on both the STELLAR study outcomes and an open-label Phase III trial in Japanese subjects.
The US Food and Drug Administration (FDA) has approved the drug for increasing exercise capacity and reducing the risk of clinical worsening events in individuals with PAH.
The therapy is also the subject of a licensing deal signed with Bristol Myers Squibb.
MSD recently reported topline outcomes from a Phase III trial of pembrolizumab for the treatment of non-small cell lung cancer.
