LYT-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Prior treatment

• Prior hospitalization for confirmed COVID-19, acute exacerbation of IPF or any lower respiratory tract infection within 3-months of Visit 1

Other illness

• Known explanation for interstitial lung disease, including but not limited to radiation, sarcoidosis, hypersensitivity pneumonitis, bronchiolitis obliterans organizing pneumonia, human immunodeficiency virus (HIV), viral hepatitis, and cancer
• Diagnosis of any connective tissue disease, including but not limited to scleroderma/systemic sclerosis, polymyositis/dermatomyositis, systemic lupus erythematosus, and rheumatoid arthritis
• Cardiovascular diseases, any of the following:
  • Uncontrolled hypertension, within 3 months of Visit 1
  • Myocardial infarction within 6 months of Visit 1
  • Unstable cardiac angina within 6 months of Visit 1

Other

• Primary obstructive airway physiology (pre-bronchodilator FEV1/FVC \< 0.7 at Visit 1)
• Major extrapulmonary physiological restriction (e.g., chest wall abnormality, large pleural effusion)

• Treatment naïve patients or those with \<6 months of exposure to nintedanib with physician diagnosed IPF based on ATS/ERS/JRS/ALAT 2018 guidelines
• Idiopathic Pulmonary Fibrosis on HRCT, performed within 12 months of Visit 1 as confirmed by central readers
• DLCO corrected for Hemoglobin (Hb) \[visit 1\] ≥ 30% and ≤90% of predicted of normal
• FVC ≥ 45% of predicted normal