- Merck & Co Inc MRK announced topline results from the pivotal Phase 3 STELLAR trial evaluating the safety and efficacy of sotatercept, an investigational activin receptor type IIA-Fc fusion protein as an add-on to stable background therapy for pulmonary arterial hypertension (PAH).
- The drug is designed to tone down inflammation in PAH patients, 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 Acceleron's pipeline, which it acquired for $11.5 billion last year.
- The company said that the primary win on a 6-minute walk distance over 24 weeks is statistically significant and clinically meaningful.
- Sotatercept also aced measures like the proportion of participants achieving multicomponent improvement and time to death or the first occurrence of a clinical worsening event.
- Eight of nine secondary efficacy outcome measures achieved statistical significance.
- The only endpoint that wasn't met was the cognitive and emotional impacts domain score of PAH-SYMPACT.
- The safety profile of sotatercept in STELLAR was generally consistent with what has been observed in Phase 2.
- Price Action: MRK shares are up 3.01% at $90.24 on the last check Monday.
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