The PROSERA study for seralutinib in pulmonary arterial hypertension findings were released yesterday and report that it did not meet its primary endpoint in the full population. It appears that unexpected placebo results in some geographical areas may have been responsible for this happening. While this is disappointing news for the patient community the program is not stopping and the results in two important sub-groups are encouraging:
There were consistent benefits in medium to high-risk PAH patients, who face the worst outcomes. This mirrors results from the earlier Phase 2 TORREY study, suggesting consistent efficacy in this vulnerable population.
Patients with connective tissue disease-associated PAH saw a significant improvement in walking distance – indicating seralutinib’s potential in this difficult-to-treat subgroup.
Even in the full population, seralutinib showed clear significant improvements in NT-proBNP levels starting as early as Week 4, and favourable trends across all secondary endpoints including time to clinical worsening.
In the meantime the open label extension is ongoing with positive results.
Gossamer Bio plans discussions with the Food & Drug Administration (FDA), the US’ regulatory Authority, to explore next steps. We look forward to hearing about the results.
Read more on the company press release at this link