TY - JOUR T1 - PBF-680, an oral A1 adenosine receptor antagonist, inhibits the late allergic response (LAR) in mild-to-moderate atopic asthmatics: a Phase-IIa trial JF - European Respiratory Journal JO - Eur Respir J DO - 10.1183/13993003.congress-2020.4784 VL - 56 IS - suppl 64 SP - 4784 AU - David Ramos-Barbon AU - Nadia S. Brienza AU - Teresa Bigorra Rodríguez AU - Éder Fredy Mateus Medina AU - Ignasi Gich Saladich AU - Montserrat Puntes Rodríguez AU - Rosa M. Antonijoan Arbos AU - Santiago Quirce Gancedo AU - Nahomi Castro Palomino Laria AU - Julio Castro Palomino Laria Y1 - 2020/09/07 UR - http://erj.ersjournals.com/content/56/suppl_64/4784.abstract N2 - Background: PBF-680 is an oral A1 adenosine receptor antagonist in development for asthma.Aims and Objectives: To evaluate PBF-680 efficacy to inhibit the LAR, a standard goal for asthma therapies development.Methods: Double-blind, randomized, cross-over trial with once-daily 10-mg PBF-680 or placebo for 5 days, on 8 atopic asthmatics on withdrawn low-to-medium-dose inhaled corticosteroid, showing both early allergic response (EAR, ≥20% FEV1 drop) and LAR (FEV1 drop ≥15% at 3-10h post-aeroallergen challenge). The primary outcome was the LAR area under the FEV1 curve (AUC3-10h). Data analysis: repeated-measures general linear model or Kruskal-Wallis/Wilcoxon.Results: LAR AUC3-10h was (mean ± standard error [SEM]) -64.84±14.14 (placebo), and 13.71±13.61 (PBF-680; P<0.001 vs. placebo,Fig. 1). EAR was -26.3% FEV1 drop (placebo) and -20.0% (PBF-680, P=0.049 vs. placebo). Exhaled breath nitric oxide fraction (FeNO, ppb) was 34.0±2.5 (placebo) and 19.7±3.0 (PBF-680, P=0.042 vs. placebo). Blood eosinophils/mcL were 283±64 (placebo) and 60±13 (PBF-680, P=0.01 vs. placebo). No relevant adverse events were recorded.Conclusions: In mild-to-moderate asthmatics, PBF-680 abrogated the LAR, and reduced the EAR, FeNO, and, remarkably, blood eosinophils, with correct safety profile. The data position the adenosine modulator PBF-680 as a promising oral asthma therapy.FootnotesCite this article as: European Respiratory Journal 2020; 56: Suppl. 64, 4784.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). ER -