Merck announces positive top-line results from STELLAR trial of sotatercept for PAH

Positive top-line results from the pivotal Phase 3 STELLAR trial evaluating the safety and efficacy of sotatercept, used as an add-on to stable background therapy for the treatment of pulmonary arterial hypertension (PAH) were announced by Merck in a company press release.

The trial met its primary efficacy outcome measure, demonstrating a statistically significant and clinically meaningful improvement in 6-minute walk distance (6MWD) from baseline at 24 weeks. In addition, 8 of 9 secondary efficacy outcome measures achieved statistical significance.

“In the Phase 3 STELLAR study, sotatercept added to currently approved background therapy showed a profound effect on the primary efficacy outcome measure of improvement from baseline to 24 weeks in six-minute walk distance. The results from the secondary efficacy outcomes, including a favorable benefit seen in patients’ time to a clinical-worsening event, are especially noteworthy,” said Dean Y. Li, MD, PhD, president, Merck Research Laboratories. “We believe that in totality, the results observed in the STELLAR study suggest that sotatercept has the potential to transform the treatment of patients with PAH. We are moving with urgency on our regulatory applications to bring this investigational therapy to these patients.”

Read the full press release here.