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

Inclusion Criteria

• •1. Clinical features consistent with IPF prior to screening (based on the American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Association (ALAT) consensus criteria for the diagnosis of IPF).
• •2. Forced (expiratory) Vital Capacity (FVC) ≥ 50% of predicted value.
• •3. DLco (corrected for hemoglobin) ≥ 30% predicted value.
• •4. Oxygen saturation \> 90% at rest by pulse oximetry while breathing ambient air or receiving ≤2 L/minute of supplemental oxygen.
• •5. Residual volume ≤ 120% predicted value.
• •6. Ratio of Forced Expiratory Volume over 1 second (FEV1) to FVC ≥ 0.65 after the use of a bronchodilator.
• •7. Other known causes of interstitial lung disease have been excluded (e.g., drug toxicities, environmental exposures, connective tissue diseases).
• •8. High Resolution Computed Tomography (HRCT) image fulfills the criteria for 'Usual Interstitial Pneumonia (UIP) pattern'.
• •9. If the HRCT image does not fulfill the criteria for 'UIP pattern' a surgical lung biopsy is necessary for the diagnosis of IPF (lung biopsy performed prior to screening is acceptable). If a lung biopsy has been performed, it must fulfill the histopathological criteria for either 'UIP pattern' or 'probable UIP pattern' with the appropriate HRCT correlate.
• •10. Adequate bone marrow and liver function.
• •11. Patient has a life expectancy of at least 12 months.