Merck, Sharp & Dohme (MSD; NYSE: MRK) has presented interim data from Phase III and extension studies for its potential first-in-class biologic sotatercept, which is being investigated for the treatment of pulmonary arterial hypertension (PAH). The late-stage trial indicated that the activin signaling inhibitor led to a reduction in right heart size and improvements in right-ventricular (RV) function, hemodynamic status, and 6-minute walk distance (6MWD) test results, demonstrating its potential therapeutic benefits in PAH.
Extension Study Highlights Long-Term Safety and Efficacy
The extension study provided evidence of sotatercept’s longer-term safety and efficacy profile. It showed a low discontinuation rate due to treatment-emergent adverse events (TEAEs), with only 1.5% of participants discontinuing treatment and 1.0% experiencing death as a result of TEAEs. These findings suggest that sotatercept may offer a sustainable treatment option for patients with PAH.
Regulatory Review and Global Submission Plans
The biologic drug sotatercept is currently under review by the US regulatory authorities, with plans for submission in other markets. The positive interim data from the Phase III and extension studies strengthen the case for sotatercept as a potential new treatment option for PAH, highlighting MSD’s commitment to advancing therapies for this condition.-Fineline Info & Tech
