The phase 2 TORREY trial found seralutinib was associated with decreased pulmonary vascular resistance (PVR) in patients with pulmonary arterial hypertension (PAH).
“Seralutinib is a PDGFR, CSF1R, and c-KIT tyrosine kinase inhibitor that can be administered by dry powder inhalation,” explained Robert Frantz, MD, at the 2023 American Thoracic Society (ATS) International Conference, held May 19-24, in Washington, DC. The phase 2, randomized, double-blind, placebo-controlled TORREY trial (NCT04456998) examined the safety and efficacy of this agent in patients with PAH (N=86). The primary endpoint was the change in PVR from baseline after 24 weeks of therapy.
The primary endpoint was met, with a change in the least-squares means of -74.9 dynes*s/cm5 for patients receiving the experimental agent compared with +21.1 for patients receiving placebo, translating to a reduction in PVR of 14.3% (P=0.031). This reduction appeared to be larger in functional class III patients (20.8%; P=0.043). Dr. Frantz added that the observed reduction of PVR and an increase in pulmonary arterial capacitance (PAC), together with a reduction in NT-proBNP, indicates that the investigational agent seralutinib is decreasing the right ventricular afterload, favoring the conditions for the right side of the heart.
According to Frantz, seralutinib was well tolerated. The most frequently observed adverse events in the investigational arm were cough (43.2%), diarrhea (13.6%), dizziness (11.4%), and nightmares (9.1%). Six treatment-emergent adverse events led to discontinuation in the seralutinib arm.
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