Gossamer Bios’ PROSERA Phase 3 PAH Trial Fails Primary Endpoint Despite 6MWD Gain
Gossamer Bios’ Phase 3 PROSERA PAH trial failed to achieve its primary endpoint, as treatment did not yield a statistically significant improvement in six-minute walk distance at the study’s conclusion. Patients receiving PROSERA showed a numerical increase in 6MWD, but the gain failed to meet the trial’s predefined statistical threshold.
1. Phase 3 PROSERA PAH Trial Overview
The PROSERA PAH trial was a randomized Phase 3 study assessing PROSERA’s efficacy in patients with pulmonary arterial hypertension, using change in six-minute walk distance as the primary outcome measure.
2. Trial Outcomes
Results showed PROSERA recipients experienced a mean numerical increase in six-minute walk distance versus baseline but failed to achieve statistical significance or meet the trial’s predefined endpoint criteria, resulting in a primary endpoint miss.
3. Program Implications and Next Steps
The company plans to review the full data set to determine next steps for the PAH program, which may include further subgroup analyses or strategic realignment of development resources.