United Therapeutics的ralinepag肺动脉高压三期结果发表于期刊但核心数据早已披露

United Therapeutics Corporation (UTHR) announced that the pivotal Phase 3 ADVANCE OUTCOMES study of Ralinepag in pulmonary arterial hypertension met its primary endpoint and key secondary endpoints, with results published in The Lancet.
Pulmonary arterial hypertension (PAH) is a rare, progressive disease characterized by high blood pressure in the arteries of the lungs, which can lead to shortness of breath, fatigue, chest pain, and heart failure if untreated. Current therapies often require complex regimens, and oral options remain limited.
Ralinepag, an investigational once-daily oral prostacyclin receptor agonist, reduced the risk of a clinical worsening event by 55% compared with placebo, demonstrating durable efficacy in delaying disease progression. The study enrolled predominantly pre-treated patients with 80% on dual background therapy and 70% classified as WHO Functional Class II at baseline.
Key secondary outcomes included a 24.3% reduction in NT-proBNP levels and a 20.4-meter improvement in six-minute walk distance versus placebo. Ralinepag also increased the odds of clinical improvement by 47%.
The safety profile was consistent with prostacyclin pathway therapies, with the most common adverse events being headache, diarrhea, nausea, and myalgia. No new safety signals were observed.
Vallerie V. McLaughlin, Chair of the ADVANCE OUTCOMES Steering Committee, noted that Ralinepag maintained durability of effect and supports its potential oral prostacyclin pathway treatment option upon FDA approval.
UTHR has traded between $272.12 and $609.35 over the past year. The stock closed Tuesday's trading at $523.63, down 0.82%.
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