New England Journal of Medicine Publishes Results of the PULSAR Phase 2 Trial of Sotatercept in Patients with Pulmonary Arterial Hypertension

Acceleron Pharma Inc. (Nasdaq: XLRN), a biopharmaceutical company dedicated to the discovery, development, and commercialization of TGF-beta superfamily therapeutics to treat serious and rare diseases, today announced that the New England Journal of Medicine has published results of the PULSAR Phase 2 trial of sotatercept in patients with pulmonary arterial hypertension (PAH).

“We couldn’t be more excited that the editors of the New England Journal of Medicine have selected the results of the PULSAR trial for publication,” said Habib Dable, President and Chief Executive Officer of Acceleron. “With our STELLAR Phase 3 registrational trial of sotatercept now enrolling patients with PAH, having such robust data highlighted in one of the world’s most prestigious peer-reviewed medical journals will help raise awareness of sotatercept’s potential to alter treatment paradigms for this disease of high unmet medical need.”

During a special session of the American Thoracic Society 2020 virtual meeting last June, study investigators reported that patients on stable background PAH-specific therapies treated with sotatercept experienced a statistically significant reduction in pulmonary vascular resistance, the trial’s primary endpoint, at week 24 versus placebo. The trial also achieved an all-dose mean improvement from baseline in the key secondary endpoint of six-minute walk distance.

“The PULSAR data show that sotatercept has the potential to deliver significant benefit on top of currently available therapies,” said Dr. Marc Humbert*, Professor of Medicine and Director of the French Pulmonary Hypertension Reference Center at the Université Paris-Saclay and a first author of the New England Journal of Medicine article. “This is a result that suggests that sotatercept could bring an important new mechanistic approach to the treatment of patients with PAH.”

Sotatercept was generally well tolerated in the trial. Adverse events observed in the study were generally consistent with previously published data on sotatercept in clinical trials in other patient populations. In addition to the ongoing STELLAR trial, Acceleron is planning two additional Phase 3 studies in PAH—HYPERION and ZENITH—evaluating sotatercept in newly diagnosed patients and in patients diagnosed with World Health Organization (WHO) functional class IV disease, respectively.