Abstract
What is this summary about?
This plain language summary shares results from a clinical study called INTEGRIS-IPF that was published in the American Journal of Respiratory and Critical Care Medicine in 2024. This study looked at a medicine called bexotegrast (beck-so-teh-grast) as a possible treatment for idiopathic pulmonary fibrosis (i-dee-uh-pa-thick pul-muh-ner-ee fie-bro-sis; IPF). Bexotegrast is an investigational medicine, which means that it is being studied and has not yet been approved by the US Food and Drug Administration (FDA), for people with IPF to take as a treatment. IPF is a chronic, progressive lung disease that makes it hard to breathe and gets worse over time. There is no cure for IPF, treatment includes symptom management and consideration for the use of nintedanib or pirfenidone, which may decrease the pace of disease progression.
The study compared bexotegrast to a placebo (a treatment that looks identical to the medicine but has no medicinal effect) to look at how well it works and how safe it is in treating people with IPF. Most people in the study also took one of two medicines that are already approved by the FDA for IPF, pirfenidone or nintedanib.
Keywords: safety, efficacy, IPF, fibrotic disease
Acknowledgments
We thank the clinical site staff, the patients who participated in this study, and all those who donate time to the evaluation of more effective treatments for IPF. Plain language summary writing and editorial support for this report were provided by Samantha O’Dwyer, PhD, of Nucleus Global Inc., and funded by Pliant Therapeutics, Inc.
Declarations
Ethics approval and consent to participate: The study design was approved by the appropriate institutional and national regulatory authorities and ethics committees; all the patients or their guardians provided written informed consent (and assent, if appropriate).
Consent for publication: All authors were involved in the preparation of this plain language summary and provided their final approval of content.
Author contributions: Lisa Lancaster: Data curation; Investigation; Writing – review & editing.
Vincent Cottin: Data curation; Investigation; Writing – review & editing.
Murali Ramaswamy: Data curation; Investigation; Writing – review & editing.
Wim A. Wuyts: Data curation; Investigation; Writing – review & editing.
R. Gisli Jenkins: Data curation; Investigation; Writing – review & editing.
Mary Beth Scholand: Data curation; Investigation; Writing – review & editing.
Michael Kreuter: Data curation; Investigation; Writing – review & editing.
Claudia Valenzuela: Data curation; Investigation; Writing – review & editing.
Christopher J. Ryerson: Data curation; Investigation; Writing – review & editing.
Jonathan Goldin: Data curation; Investigation; Writing – review & editing.
Grace Hyun J. Kim: Data curation; Investigation; Writing – review & editing.
Marzena Jurek: Data curation; Investigation; Writing – review & editing.
Martin Decaris: Data curation; Investigation; Writing – review & editing.
Annie Clark: Data curation; Formal analysis; Investigation; Writing – review & editing.
Scott M. Turner: Data curation; Investigation; Writing – review & editing.
Chris N. Barnes: Data curation; Formal analysis; Investigation; Writing – review & editing.
Hardean E. Achneck: Data curation; Investigation; Writing – review & editing.
Gregory P. Cosgrove: Data curation; Investigation; Writing – review & editing.
Éric A. Lefebvre: Conceptualization; Data curation; Investigation; Writing – review & editing.
Kevin R. Flaherty: Data curation; Investigation; Writing – review & editing.
Funding: The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This study was paid for by Pliant Therapeutics, Inc.
MJ, MD, AC, ST, HA, GC, CNB, and EL were employed by Pliant Therapeutics, Inc. and own stock at the time of this analysis. LL received grants from Roche, Pliant Therapeutics Inc, Fibrogen, Boehringer Ingelheim, Novartis, Celgene, Galecto, Bristol Myers Squibb, Bridge Biotherapeutics, Horizon, CSL Behring, and NeRRe; consulting fees from DevProBiopharma, Pieries, AstraZeneca, Oxygenium, Roche, Bellerophon, Senwha, Daewoong, Daiichi Sankyo, Nashville Biosciences, Veracyte, United Therapeutics, Structure Therapeutics, Fortress Biotech, Tvardi, ureTech, and SynDevRx; honoraria from Boehringer Ingelheim, Genentech, Veracyte, and United Therapeutics; has patent pending for Aut02; participated in a Data Safety Monitoring Board or Advisory Board for DevProBiopharma, Pieris, Oxygenium, Bellerophon, Veracyte, United Therapeutics, and Aerami. WAW received grants/fees paid to their institution from Pliant Therapeutics, Inc. GJ: received grants paid to their institution from AstraZeneca, Biogen, Galecto, GSK, Nordic Bioscience, Pliant Therapeutics, Inc., and RedV; consulting fees from AstraZeneca, Brainomix, Bristol Myers Squibb, Chiesi, CohBar, Daewoong Pharmaceutical, GSK, Pliant Therapeutics, Inc., Resolution Therapeutics, and Veracyte; honoraria from AstraZeneca, Boehringer Ingelheim, Chiesi, patientMpower, and Roche; payment for expert testimony from Pinsent Masons LLP; and participates on a DSMB/advisory board/other board for Action for Pulmonary Fibrosis, Boehringer Ingelheim, Galapagos, NuMedii, and Vicore Pharma. MK’s previous institution received grants from Boehringer Ingelheim and Roche. CV received honoraria/consulting fees from BMS, Boehringer Ingelheim, and Roche. JG is the founder of MedQIA LLC. GK is a consultant for MedQIA LLC. MR is a co-Founder of Pulmonix, LLC clinical trial services practice. VC received consulting fees from Pliant Therapeutics, Inc. MBS: received consulting and speaker fees from Boehringer Ingelheim, Genentech, Veracyte, Imvaria and United Therapeutics. CR received institutional grant from Boehringer Ingelheim; consulting fees from Boehringer Ingelheim, Pliant Therapeutics, AstraZeneca, Trevi Therapeutics and Veracyte; honoraria from Boehringer Ingelheim, Cipla and F. Hoffmann - La Roche; expert testimony fees from Boehringer Ingelheim; meeting support from Boehringer Ingelheim and Copla. KF received institutional grant from Boehringer Ingelheim; consulting fees from Arrowhead, AstraZeneca, Bellerophone, CSL Behring, Daewoong, DevPro, Dispersol, FibroGen, F. Hoffman La - Roche/Genentech, Horizon, Immunet, Insilco, Lupin, NeRRe Therapeutics, Pliant Therapeutics, Polarean, Pure Health, Pure Tech, Respivant, Shinogi, Sun Pharmaceuticals, Trevi, United Therapeutics, and Vicore; and is the Steering Committee Chair for the Pulmonary Fibrosis Foundation.
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