PT  - JOURNAL ARTICLE
AU  - Lefebvre, Eric
AU  - Coulie, Bernard
AU  - Jurek, Marzena
AU  - Bellini, Jonathan
AU  - Cilli, Fiona
AU  - Wong, Simon
AU  - Decaris, Martin
AU  - Turner, Scott
AU  - Park, Erica
TI  - INTEGRIS-IPF: a 12-week, Phase 2a study evaluating the safety, tolerability and pharmacokinetics of PLN-74809 in participants with IPF
AID  - 10.1183/13993003.congress-2020.782
DP  - 2020 Sep 07
TA  - European Respiratory Journal
PG  - 782
VI  - 56
IP  - suppl 64
4099  - http://erj.ersjournals.com/content/56/suppl_64/782.short
4100  - http://erj.ersjournals.com/content/56/suppl_64/782.full
SO  - Eur Respir J2020 Sep 07; 56
AB  - Integrins αvβ6 and αvβ1 are upregulated in IPF-diseased lungs, playing a key role in promoting TGF-β activation and fibrosis progression. PLN-74809 is an oral, once-daily, highly selective inhibitor of integrins αVβ6 and αVβ1 with good tolerability observed in >100 healthy Phase 1 study participants. PLN-74809 showed potent antifibrotic activity in animal models of lung fibrosis and in live precision-cut tissue slices from explanted IPF lungs, and reduced TGF-β activation in the lungs of healthy volunteers.INTEGRIS-IPF (PLN-74809-IPF-202) is a Phase 2a, randomized, dose-ranging, double-blind, placebo-controlled study evaluating the safety, tolerability, and pharmacokinetics (PK) of PLN-74809 administered over 12 weeks in participants with IPF (ATS/ERS/JRS/ALAT 2018). Up to approximately 80 participants with IPF will be enrolled in up to 4 dose groups, with a 3:1 randomization ratio (active:placebo) and stratification based on use of standard of care (SoC) therapy (pirfenidone or nintedanib [yes/no]). Key eligibility criteria include: ≥40 years of age; FVC ≥45% of predicted; DLCO ≥30%; FEV1/FVC ratio ≥0.7; if receiving SoC, must be on a stable regimen for ≥3 months; no recent acute IPF exacerbation.The primary endpoint is the evaluation of PLN-74809 safety and tolerability; the secondary endpoint is the assessment of PK across a dose range. Exploratory endpoints will measure change in FVC, HRCT-based Quantitative Lung Fibrosis score, cough symptoms via visual analog scale, and selected biomarkers over 12 weeks of treatment. Research sites will enroll across approximately 10 participating countries from Australasia, Europe and North America.FootnotesCite this article as: European Respiratory Journal 2020; 56: Suppl. 64, 782.This abstract was presented at the 2020 ERS International Congress, in session “Respiratory viruses in the "pre COVID-19" era”.This is an ERS International Congress abstract. No full-text version is available. Further material to accompany this abstract may be available at www.ers-education.org (ERS member access only).