For Healthcare Providers

In this Phase 2b/3 trial, the efficacy and safety of the investigational drug bexotegrast will be investigated in patients with IPF to assess its potential impact on slowing or halting disease progression over a 52-week treatment period by reducing scar formation (fibrosis) of the lungs.

The primary outcome measure of this trial is:

  • Change from baseline in absolute FVC (mL) at Week 52

This trial will also measure:

  • Time to disease progression
  • Absolute FVC (mL) change in participants on and off IPF background therapy
  • A patient-reported measurement of symptoms and well-being
  • Safety and tolerability
  • Fibrosis biomarkers

About Bexotegrast

Bexotegrast is an investigational drug that is currently being studied in clinical trials as a potential treatment for IPF.

Bexotegrast is an oral, small molecule, dual-selective inhibitor of integrins αvβ6 and αvβ1 designed to block TGF-β mediated fibroblast-to-myofibroblast transition and collagen synthesis.

Eligibility Criteria

  • 40 years of age or older at screening
  • Diagnosis of IPF based upon ATS/ERS/JRS/LATA current guidelines within 7 years from screening
  • Clinical evidence of active infection, including, but not limited to bronchitis, pneumonia, or sinusitis that can affect FVC measurement during screening or at randomization
  • Known acute IPF exacerbation, or suspicion by the Investigator of such, 6 months prior to screening
  • FVCpp ≥45%
  • Diffusing capacity for carbon monoxide percent predicted (hemoglobin-adjusted) ≥30% and <90%
  • Forced expiratory volume in the first second/FVC ratio <0.7 at screening
  • Patients on and off IPF background therapy (i.e. nintedanib or pirfenidone) are eligible for enrollment
  • Receiving drug therapy for pulmonary hypertension
  • Receiving any unapproved or investigational agent intended for treatment of fibrosis in IPF
FVC=forced vital capacity; IPF=idiopathic pulmonary fibrosis.