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 volunteers 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

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 IPF background therapy (i.e. nintedanib or pirfenidone) are eligible for enrollment

Exclusion

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.

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Bexotegrast is an investigational drug and is not approved by any health authority.

For Healthcare Providers

The primary outcome measure of this trial is:

This trial will also measure:

About Bexotegrast

Eligibility Criteria

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