TORREY, a Phase 2 study to evaluate the efficacy and safety of inhaled seralutinib for the treatment of pulmonary arterial hypertension
| العنوان: | TORREY, a Phase 2 study to evaluate the efficacy and safety of inhaled seralutinib for the treatment of pulmonary arterial hypertension |
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| المؤلفون: | David Mottola, Raymond L. Benza, Robert P. Frantz, Anna R. Hemnes, Robert Roscigno, Jean-Marie Bruey, Richard N. Channick, Hossein Ardeschir Ghofrani, Roham T. Zamanian, Luke Howard, Vallerie V. McLaughlin, Kelly Chin, Erin Elman, Olivier Sitbon, Lawrence S. Zisman, Matt Cravets |
| المصدر: | Pulmonary Circulation, Vol 11 (2021) Pulmonary Circulation |
| بيانات النشر: | SAGE Publishing, 2021. |
| سنة النشر: | 2021 |
| مصطلحات موضوعية: | Pulmonary and Respiratory Medicine, medicine.medical_specialty, PDGFR, Vascular remodelling in the embryo, Colony stimulating factor 1 receptor, Diseases of the respiratory system, Growth factor receptor, Fibrosis, Internal medicine, c-KIT, Clinical endpoint, Medicine, Diseases of the circulatory (Cardiovascular) system, Original Research Article, RC705-779, business.industry, BMPR2, CSF1R, medicine.disease, Pulmonary hypertension, medicine.anatomical_structure, RC666-701, Cardiology, Vascular resistance, GB002, business, pulmonary vascular remodeling |
| الوصف: | Aberrant kinase signaling that involves platelet-derived growth factor receptor (PDGFR) α/β, colony stimulating factor 1 receptor (CSF1R), and stem cell factor receptor (c-KIT) pathways may be responsible for vascular remodeling in pulmonary arterial hypertension. Targeting these specific pathways may potentially reverse the pathological inflammation, cellular proliferation, and fibrosis associated with pulmonary arterial hypertension progression. Seralutinib (formerly known as GB002) is a novel, potent, clinical stage inhibitor of PDGFRα/β, CSF1R, and c-KIT delivered via inhalation that is being developed for patients with pulmonary arterial hypertension. Here, we report on an ongoing Phase 2 randomized, double-blind, placebo-controlled trial (NCT04456998) evaluating the efficacy and safety of seralutinib in subjects with World Health Organization Group 1 Pulmonary Hypertension who are classified as Functional Class II or III. A total of 80 subjects will be enrolled and randomized to receive either study drug or placebo for 24 weeks followed by an optional 72-week open-label extension study. The primary endpoint is the change from baseline to Week 24 in pulmonary vascular resistance by right heart catheterization. The secondary endpoint is the change in distance from baseline to Week 24 achieved in the 6-min walk test. A computerized tomography sub-study will examine the effect of seralutinib on pulmonary vascular remodelling. A separate heart rate monitoring sub-study will examine the effect of seralutinib on cardiac effort during the 6-min walk test. |
| اللغة: | English |
| تدمد: | 2045-8940 0445-6998 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::2c45d55dd40b9fc8f6a8c007967a2a96Test https://doaj.org/article/e7c6ee3ea34a41f89721a2c6c04b54deTest |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....2c45d55dd40b9fc8f6a8c007967a2a96 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 20458940 04456998 |
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