The Company now expects to report top-line results during the first quarter of 2020.
“We’re thrilled with PULSAR’s rapid enrollment over the past 12 months, which underscores the urgency for new therapeutic options for patients with PAH,” said Janethe de Oliveira Pena, MD, PhD, Vice President, Pulmonary Medical Research at Acceleron. “We believe that through its targeting of underlying disease mechanisms, sotatercept, when combined with standard-of-care therapies, has the potential to alter the PAH treatment landscape.”
The PULSAR trial has enrolled 100 patients with PAH. Additional patients who are currently in screening remain eligible for randomization into the trial over the next few weeks. Acceleron is also enrolling patients with PAH in the Phase 2 SPECTRA exploratory trial of sotatercept.
Sotatercept is an investigational therapy that is not approved for any use in any country.
About the PULSAR Trial
The PULSAR Phase 2 trial is a randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of sotatercept in PAH patients. The primary endpoint of the trial is the change from baseline in pulmonary vascular resistance (PVR) over a 24-week treatment period. The key secondary endpoint is change from baseline in six-minute walk distance (6MWD). A total of at least 100 patients will be randomized in a 3:3:4 ratio to receive placebo, sotatercept 0.3 mg/kg, or sotatercept 0.7 mg/kg subcutaneously every 21 days with standard-of-care therapies in combination. Following the 6-month double-blind treatment period, participants in the trial will be eligible to continue in the 18-month extension period.
Source: Company Press Release