The first clinical site is now active for a global Phase 3 study that will evaluate Gossamer Bio’s therapy candidate seralutinib for people with pulmonary hypertension associated with interstitial lung disease (PH-ILD). The study, titled SERANATA, aims to enroll around 480 patients aged 18 to 80, randomised to receive either 90 mg or 120 mg twice-daily seralutinib, or placebo, for 24 weeks, followed by a long-term extension phase of 144 weeks.
The primary endpoint of the first part of the trial is change in the six-minute walk distance (6MWD), with secondary outcomes including time to clinical worsening and changes in forced vital capacity (FVC) as a measure of lung function.
If positive, the trial results could support a submission for regulatory approval of seralutinib for people with this particular form of pulmonary hypertension.
Summary by Deger Kesimoglu, volunteer for the Alliance for Pulmonary Hypertension
Read more on Pulmonary Hypertension News at this link and the company press release here