Seralutinib in adults with pulmonary arterial hypertension (TORREY): a randomised, double-blind, placebo-controlled phase 2 trial

BACKGROUND: Morbidity and mortality in pulmonary arterial hypertension (PAH) remain high. Activation of platelet-derived growth factor receptor, colony stimulating factor 1 receptor, and mast or stem cell growth factor receptor kinases stimulates inflammatory, proliferative, and fibrotic pathways driving pulmonary vascular remodelling in PAH. Seralutinib, an inhaled kinase inhibitor, targets these pathways. We aimed to evaluate the efficacy and safety of seralutinib in patients with PAH receiving standard background therapy. METHODS: The TORREY trial was a phase 2, randomised, multicentre, multinational, double-blind, placebo-controlled study. Patients with PAH from 40 hospital and community sites were randomly assigned 1:1 via interactive response technologies to receive seralutinib (60 mg twice daily for 2 weeks, then increased to 90 mg twice daily as tolerated) or placebo by dry powder inhaler twice daily for 24 weeks. Randomisation was stratified by baseline pulmonary vascular resistance (PVR; <800 dyne·s/cm(5) and

• Frantz, R. P.
• McLaughlin, V. V.
• Sahay, S.
• Escribano Subías, P.
• Zolty, R. L.
• Benza, R. L.
• Channick, R. N.
• Chin, K. M.
• Hemnes, A. R.
• Howard, L. S.
• Sitbon, O.
• Vachiéry, J. L.
• Zamanian, R. T.
• Cravets, M.
• Roscigno, R. F.
• Mottola, D.
• Osterhout, R.
• Bruey, J. M.
• Elman, E.
• Tompkins, C. A.
• Parsley, E.
• Aranda, R.
• Zisman, L. S.
• Ghofrani, H. A.