Merck just announced that its pulmonary arterial hypertension (PAH) drug candidate sotatercept delivered positive results in a pivotal Phase 3 clinical trial, potentially paving the way for a multibillion-dollar therapeutic and new hope for PAH patients.
Merck bought Acceleron last year for $11B in order to gain access to sotatercept, hoping to bulk up its portfolio before its blockbuster cancer drug Keytruda goes off patent in 2028. The company wagered that sotatercept had the potential to make it to market and buffer revenue losses in the face of generic competition. So far, the bet appears to be paying off.
PAH Patients in Merck’s STELLAR trial demonstrated a “statistically significant and clinically meaningful” improvement in 6-minute walk distance from baseline at 24 weeks when added to background therapy (the primary endpoint). Eight of nine secondary endpoints were also met. The company plans to present detailed results at an upcoming conference.
A new add-on treatment for pulmonary arterial hypertension may be on the horizon. The STELLAR data validates the Acceleron acquisition and bolsters Merck’s portfolio of cardiovascular drugs ahead of its upcoming patent cliff, and a promising new PAH drug may be on the way.