Study to Evaluate Safety and Efficacy of Mirivadelgat in PH-ILD

Exclusion criteria

• ✕. Subject has another concomitant diagnosis of pulmonary hypertension not otherwise considered to be PH-ILD. This would include and is not limited to the concomitant presence of thromboembolic disease, untreated/inadequately treated obstructive sleep apnea, human immunodeficiency virus (HIV), methamphetamine or anorexigenic drug use, and other conditions of the WHO Group 1, 2, 4, and 5 classifications.
• ✕. Subject has evidence of clinically significant left-sided heart disease within 6 months as defined by:
• ✕. Subjects must NOT have 3 or more of the following left ventricular disease/dysfunction risk factors at screening:
• ✕. History of myocardial infarction or acute coronary syndrome (unstable angina), or
• ✕. Percutaneous coronary intervention or percutaneous transluminal angioplasty, or previous coronary artery bypass graft, or
• ✕. Evidence of coronary artery disease (\>50% stenosis in at least one major coronary artery) or abnormal nuclear stress test.
• ✕. The subject is receiving \>10 L/min of oxygen supplementation by any mode of delivery at rest.
• ✕. The subject has received any PH-approved therapy, including phosphodiesterase type 5 inhibitor, soluble guanylate cyclase inhibitor, endothelin receptor antagonist, or parenteral or oral prostacyclin therapy (excluding vasoreactivity testing) within 60 days of randomization or 5 half-lives. Inhaled prostacyclin (e.g., inhaled treprostinil) on stable doses for ≥30 days prior to screening will be allowed irrespective of local approval (as per ESC/ERS 2022).