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TORREY trial: seralutinib associated with reduced pulmonary vascular resistance in PAH

Presented by
Prof. Robert Frantz, Mayo Clinic, MN, USA
ATS 2023
Phase 2, TORREY
Seralutinib was associated with decreased pulmonary vascular resistance (PVR) in patients with pulmonary arterial hypertension (PAH). According to the authors, the encouraging results of the current phase 2 TORREY trial have instigated the initiation of a global phase 3 trial. 

“Seralutinib is a PDGFR, CSF1R, and c-KIT tyrosine kinase inhibitor that can be administered by dry powder inhalation,” explained Prof. Robert Frantz (Mayo Clinic, MN, USA) at the start of his talk. The phase 2, randomised, double-blind, placebo-controlled TORREY trial (NCT04456998) examined the safety and efficacy of this agent in patients with PAH (n=86) [1]. 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). Prof. 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 experimental agent seralutinib is decreasing the right ventricular afterload, favouring the conditions for the right side of the heart.  

According to Prof. Frantz, seralutinib was well tolerated. The most frequently observed adverse events in the experimental arm were cough (43.2%), diarrhoea (13.6%), dizziness (11.4%), and nightmares (9.1%). Finally, there were 6 treatment-emergent adverse events that led to discontinuation in the seralutinib arm. 

  1. Frantz RP, et al. Seralutinib treatment in adult subjects with pulmonary arterial hypertension: results from the TORREY study. Session B13, ATS International Conference 2023, 19–24 May, Washington DC, USA. 


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