- Merck & Co Inc MRK announced topline results from the pivotal Phase 3 STELLAR study evaluating the safety and efficacy of sotatercept, an investigational activin receptor type IIA Fc fusion protein, as an adjunct to stable background Therapy of pulmonary arterial hypertension (PAH).
- The drug aims to reduce inflammation in patients with PAH, a rare type of high blood pressure that affects the arteries in the lungs and the right side of the heart.
- Merck added sotatercept, the lead drug in Accelerons pipeline it acquired for $11.5 billion last year.
- The company said the primary gain in a 6-minute walk over 24 weeks is statistically significant and clinically meaningful.
- Sotatercept also improved measures such as the proportion of participants achieving multicomponent improvement and time to death or first occurrence of a clinical worsening event.
- Eight of nine secondary efficacy endpoints reached statistical significance.
- The only endpoint that was not met was the area score of cognitive and emotional effects of PAH-SYMPACT.
- The safety profile of sotatercept in STELLAR was generally consistent with the Phase 2 observations.
- Price promotion: MRK shares are up 3.01% to $90.24 on the latest check Monday.
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