The Phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of oral Inhalation of seralutinib for the treatment of pulmonary arterial hypertension is on track to start in September 2023. The primary objective of the study is to determine the effect of seralutinib on improving exercise capacity in subjects with WHO Group 1 pulmonary arterial hypertension who are Functional Class II or III. The secondary objective for this trial is to determine time to clinical worsening.
Seralutinib is a tyrosine kinase inhibitor designed to be delivered via dry powder inhaler. It targets the mechanisms behind pathological inflammation, cellular proliferation, and fibrosis associated with pulmonary arterial hypertension progression. We reported on the results of the Phase 2 TORREY clinical trial on seralutinib in an article published in December 2022 (check this link)
Find out more about the Phase 3 study at this link on the clinicaltrials.gov website, last updated on July 7, 2023
Read more at this link on the RareDiseaseAdvisor website
See also recent article titled “Pharmacology and Rationale for Seralutinib in the Treatment of Pulmonary Arterial Hypertension” at this link on the web page of the International Journal of Molecular Science.