PAH treatment moves in a disease-modifying direction with Merck data
Sotatercept meets primary and most secondary endpoints in Phase III pulmonary arterial hypertension study
A first pulmonary hypertension therapy with targeted, disease-modifying activity is headed for regulatory review with the announcement from Merck that sotatercept met the primary endpoint and eight of nine secondary endpoints in the Phase III STELLAR study.
Though full data were not disclosed, Merck Co. Inc. (NYSE:MRK) said sotatercept led to a statistically significant and clinically meaningful improvement in the 6-minute walk distance (6MWD) test at 24 months from baseline. The therapy failed to statistically improve the cognitive/emotional impacts domain score of the PAH-SYMPACT test, but met all other secondary endpoints, including time to death or first occurrence of clinical worsening...