Gossamer Bio has announced that the TORREY Phase 2 study of its GB002 seralutinib DPI for the treatment of pulmonary arterial hypertension (PAH) met its primary endpoint, demonstrating a statistically significant change in pulmonary vascular resistance (PVR) at Week 24. According to Gossamer, “Seralutinib is a tyrosine kinase inhibitor targeting PDGFRα/β, CSF1R, and c-KIT, specifically designed to be delivered via dry powder inhaler for the treatment of pulmonary hypertension.”
The TORREY trial enrolled 86 PAH patients who received either twice-daily seralutinib or inhaled placebo over 24 weeks in addition to their usual care. In addition to a 14.3% relative improvement in PVR for seralutinib vs placebo, the study also demonstrated a statistically significant improvements in a heart stress biomarker and other measures of heart health as well as improvement in 6-minute walk distance for seralutinib vs placebo.
Gossamer Chairman and CEO Faheem Hasnain commented, “We are very pleased to share that seralutinib significantly improved hemodynamic, biomarker, and right heart structural and functional measures in a heavily treated PAH patient population. Importantly, these efficacy results were paired with a favorable safety and tolerability profile, something that has challenged past development of tyrosine kinase inhibitors in PAH.”
Read the Gossamer Bio press release.
