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Seralutinib Shows Sustained Benefits in PAH Responders Over 72-Week Treatment Period

  • Long-term seralutinib treatment demonstrated continued improvement in pulmonary vascular resistance through 72 weeks in PAH patients, with responders showing a median 32% reduction.

  • Patients classified as responders exhibited superior outcomes in cardiac output (19.6% vs 1.8%) and mean pulmonary arterial pressure reduction (-11.8% vs -7.7%) compared to the total cohort.

  • The treatment maintained a favorable safety profile over the extended period, with common side effects including COVID-19, headache, and epistaxis.

In a significant development for pulmonary arterial hypertension (PAH) treatment, extended analysis of seralutinib therapy reveals sustained benefits, particularly in patients identified as treatment responders. The findings, presented at the Pulmonary Vascular Research Institute 2025 Annual Congress, build upon the earlier positive results from the phase 2 TORREY study.
A post-hoc analysis of the open-label extension study, led by Dr. Raymond L. Benza from the Icahn School of Medicine at Mount Sinai, examined 28 PAH patients who received twice-daily 90 mg inhaled seralutinib over 72 weeks. The research team identified a notable response pattern, with 17 patients qualifying as "responders" by achieving greater than 15% decrease in pulmonary vascular resistance (PVR).

Marked Improvements in Key Clinical Measures

The responder group demonstrated remarkable improvements across multiple clinical parameters. These patients achieved a median PVR reduction of 32%, with individual responses ranging from 17% to 62% improvement. Notably, three patients reached a significant milestone with their PVR dropping below 200 dyne*s/cm5 at the 72-week mark.
Responders showed substantially better outcomes compared to the total cohort across key measurements:
  • Cardiac output improved by 19.6% in responders versus 1.8% in the total group
  • Mean pulmonary arterial pressure decreased by 11.8% in responders compared to 7.7% in the total group
  • 6-minute walk distance increased by 38.6 meters in responders versus 29.8 meters in the total group

Safety Profile and Adverse Events

The extended treatment period revealed a consistent safety profile with no new concerns emerging during the open-label extension. Common treatment-emergent adverse events included:
  • COVID-19 (28.6% in total group, 23.5% in responders)
  • Headache (25% in total group, 29.4% in responders)
  • Epistaxis (21.4% in total group, 23.5% in responders)
  • Nausea (21.4% in total group, 17.6% in responders)

Clinical Implications

While acknowledging the limitations inherent in open-label studies and post-hoc analyses, these findings suggest that seralutinib offers sustained therapeutic benefits in PAH patients, particularly in those who demonstrate early response to treatment. The continued PVR improvement through 72 weeks of treatment in a low-risk, heavily treated population provides encouraging evidence for the drug's long-term efficacy.
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