For Healthcare Providers

In this Phase 2b study, the efficacy and safety of the investigational drug bexotegrast (formerly PLN-74809) 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 study is:

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

This study will also measure:

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

About Bexotegrast
(formerly PLN-74809)

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

Inclusion
  • 40 years of age or older at screening
  • Diagnosis of IPF based upon ATS/ERS/JRS/LATA current guidelines within 7 years from screening
Exclusion
  • 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
Inclusion
  • FVCpp ≥ 45%
  • Diffusing capacity for carbon monoxide percent predicted (hemoglobin-adjusted) ≥ 30% and < 90%
Exclusion
  • Forced expiratory volume in the first second/FVC ratio < 0.7 at screening
Inclusion
  • Patients on and off background therapy (e.g. nintedanib or pirefenidone) are eligible for enrollment
Exclusion
  • Receiving drug therapy for pulmonary hypertension
  • Receiving any unapproved or investigational agent intended for treatment of fibrosis in IPF