{"id":54536,"date":"2023-03-06T18:05:27","date_gmt":"2023-03-06T17:05:27","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/mercks-investigational-activin-signaling-inhibitor-sotatercept-improved-six-minute-walk-distance-by-40-8-meters-at-week-24-versus-placebo-in-adults-with-pulmonary-arterial-hypertension-on-bac\/"},"modified":"2023-03-06T18:05:27","modified_gmt":"2023-03-06T17:05:27","slug":"mercks-investigational-activin-signaling-inhibitor-sotatercept-improved-six-minute-walk-distance-by-40-8-meters-at-week-24-versus-placebo-in-adults-with-pulmonary-arterial-hypertension-on-bac","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/mercks-investigational-activin-signaling-inhibitor-sotatercept-improved-six-minute-walk-distance-by-40-8-meters-at-week-24-versus-placebo-in-adults-with-pulmonary-arterial-hypertension-on-bac\/","title":{"rendered":"Merck\u2019s Investigational Activin Signaling Inhibitor Sotatercept Improved Six-Minute Walk Distance by 40.8 Meters at Week 24 Versus Placebo in Adults with Pulmonary Arterial Hypertension on Background Therapy"},"content":{"rendered":"
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\nSotatercept demonstrated statistically significant improvements in 8 of 9 secondary measures, including reduction in risk of clinical worsening or death<\/b>\n<\/p>\n

\nResults presented today at ACC.23\/WCC and published in The New England Journal of Medicine<\/i><\/b>\n<\/p>\n

RAHWAY, N.J.–(BUSINESS WIRE)–$MRK<\/a> #MRK<\/a>–Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced full results from the Phase 3 STELLAR trial, which evaluated sotatercept, Merck\u2019s novel investigational activin signaling inhibitor biologic, in combination with stable background therapy for the treatment of adult patients with pulmonary arterial hypertension (PAH) (WHO Group 1). Sotatercept significantly improved exercise capacity, increasing 6-minute walk distance (6MWD) by 40.8 meters (95% CI, 27.5-54.1; p<0.001) from baseline at week 24, the study\u2019s primary endpoint.\n<\/p>\n

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\nIn addition, sotatercept demonstrated statistically significant and clinically meaningful improvements in eight of nine secondary outcome measures, including improvements in WHO functional class (WHO FC) and pulmonary vascular resistance (PVR). Sotatercept reduced the risk of clinical worsening or death by 84% compared to placebo with a median follow-up of 32.7 weeks (HR=0.16 [95% CI, 0.08-0.35]; p<0.001). The safety profile of sotatercept was generally consistent with that observed in previous studies with sotatercept. These data were presented today at the American College of Cardiology\u2019s 72nd<\/sup> Annual Scientific Session together with World Heart Federation\u2019s World Congress of Cardiology and simultaneously published in The New England Journal of Medicine<\/i><\/a>.\n<\/p>\n

\n\u201cPAH is a rare, rapidly progressive, debilitating and ultimately life-threatening condition with a five-year mortality rate of 43 percent,\u201d said Dr. Marius Hoeper, Hannover Medical School, Germany, and lead investigator. \u201cSotatercept demonstrated profound improvements across the primary endpoint of six-minute walk distance and multiple secondary endpoints, including improvements in WHO functional class and pulmonary vascular resistance. These landmark results show the potential of sotatercept and the approach of targeting cellular signaling associated with vascular hyperproliferation and pathological remodeling for the treatment of PAH.\u201d\n<\/p>\n

\n\u201cThe results from the Phase 3 STELLAR trial are immensely important to physicians and patients and highlight the critical role sotatercept may play in improving exercise capacity and other meaningful clinical outcome measures for patients with PAH,\u201d said Dr. Dean Y. Li, president, Merck Research Laboratories. \u201cThese findings are compelling given the profound reduction in the risk of clinical worsening or death in patients treated with sotatercept on top of background therapy. We look forward to discussing these pivotal data with health authorities and are working with urgency to bring this potential new treatment option to patients.\u201d\n<\/p>\n

\nSTELLAR is the first Phase 3 study to evaluate the efficacy of an activin signaling inhibitor added to background therapy in adults with PAH. Key findings from secondary endpoints included:\n<\/p>\n