Phase I studies of acebilustat: biomarker response and safety in patients with cystic fibrosis
File(s)
Published version
Author(s)
Type
Journal Article
Abstract
There is a significant unmet need for safe and effective anti-inflammatory treatment for cystic fibrosis. The aim of this study was to evaluate the safety of acebilustat, a leukotriene A4 hydrolase inhibitor, and its effect on inflammation biomarkers in patients with cystic fibrosis. Seventeen patients with mild to moderate cystic fibrosis were enrolled and randomized into groups receiving placebo or doses of 50 mg or 100 mg acebilustat administered orally, once daily for 15 days. Sputum neutrophil counts were reduced by 65% over baseline values in patients treated with 100 mg acebilustat. A modestly significant 58% reduction vs. placebo in sputum elastase was observed with acebilustat treatment. Favorable trends were observed for reduction of serum C-reactive protein and sputum neutrophil DNA in acebilustat-treated patients. No changes in pulmonary function were observed. Acebilustat was safe and well tolerated. The results of this study support further clinical development of acebilustat for treatment of cystic fibrosis.
Date Issued
2016-11-02
Date Acceptance
2016-09-22
Citation
Clinical and Translational Science, 2016, 10 (1), pp.28-34
ISSN
1752-8054
Publisher
Wiley
Start Page
28
End Page
34
Journal / Book Title
Clinical and Translational Science
Volume
10
Issue
1
Copyright Statement
© 2016 The Authors. Clinical and Translational Science published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics. This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.
Sponsor
National Institute for Health Research
Royal Brompton & Harefield NHS Foundation Trust
Grant Number
BRU 6535
RBRU funding Apr13 Mar17
Subjects
General Clinical Medicine
1102 Cardiovascular Medicine And Haematology
1112 Oncology And Carcinogenesis
1199 Other Medical And Health Sciences
Publication Status
Published