October 10, 2022
Merck announced positive data of sotatercept for PAH.
Merck announced the top-line results of Phase 3 STELLAR trial, evaluating the efficacy of sotatercept in addition to the background standard of care in patients with pulmonary arterial hypertension. The study met the primary endpoint, demonstrating statically significant improvement in 6-minute walk distance at 24 weeks versus placebo.
STELLAR is a randomized, placebo-controlled study that evaluates the efficacy of sotatercept versus placebo. In addition to meeting the primary endpoint, the study has met eight out of nine secondary endpoints.
Sotatercept is an activin receptor type IIA-Fc (ActRIIA-Fc) fusion protein, which is believed to balance pro-proliferative and anti-proliferative signaling. It has received Breakthrough Therapy designation from the US Food and Drug Administration and PRIME designation from European Medicines Agency.
Merck received global rights for the development of sotatercept through the Acceleron Pharma acquisition and is subjected to licensing agreement with Bristol Myers Squibb.