Pulmonary Hypertension associated with Interstitial Lung Disease (PH-ILD) is a collection of rare, progressive and often fatal forms of pulmonary hypertension that affect the small airways of the lungs. PH-ILD includes pulmonary hypertension associated with idiopathic pulmonary fibrosis (PH-IPF) and pulmonary hypertension related to connective tissue disease-associated interstitial lung disease (PH related to CTD-ILD), amongst others.
Based on internal company estimates, we believe that there are currently 60,000 to potentially over 100,000 people living with PH-ILD in the United States. The three year survival rate for PH-ILD patients has been reported to be 40%.
These diseases are characterized by pulmonary vascular pathology associated with pulmonary hypertension, in addition to thickening and scarring of the lung interstitium from interstitial lung disease. By addressing the mechanisms that underlie the pulmonary hypertension, including inflammation, proliferation, and fibrosis, we believe that seralutinib holds the potential to benefit patients living with PH-ILD.
Gossamer Bio reported positive topline results from its completed Phase 2 TORREY Study in December 2022. The same pathological mechanisms involved in PAH are involved in PH-ILD. We expect to initiate a global registrational Phase 3 clinical trial for the treatment of PH-ILD mid-2025.