GLPG2737 on Top of Orkambi in Subjects With Cystic Fibrosis

Summary

This is a Phase IIa, multi-center, randomized, double-blind, placebo-controlled, parallel-group study to evaluate GLPG2737 administered orally b.i.d. for 28 days to adult male and female subjects with a confirmed diagnosis of cystic fibrosis homozygous for the F508del CFTR mutation and on stable treatment with Orkambi.

Timeline

Start

2017-11-29

Primary completion

2018-04-10

Completion

2018-04-10

Outcome

Met primary endpoint

paper A significant decrease from baseline in mean sweat chloride concentration occurred at day 28 for GLPG2737 versus placebo PMID 31594690 ↗

release “First trial to evaluate C2 corrector GLPG2737 in CF patients treated with Orkambi GLPG2737 achieved primary efficacy endpoint” lakefrontbio.com ↗

Publications

• van Koningsbruggen-Rietschel S, Conrath K, Fischer R, Sutharsan S, Kempa A, Gleiber W, Schwarz C, Hector A, Van Osselaer N, Pano A, Corveleyn S, Bwirire D, Santermans E, Muller K, Bellaire S, Van de Steen O. GLPG2737 in lumacaftor/ivacaftor-treated CF subjects homozygous for the F508del mutation: A randomized phase 2A trial (PELICAN). J Cyst Fibros. 2020 Mar;19(2):292-298. doi: 10.1016/j.jcf.2019.09.006. Epub 2019 Oct 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	GLPG2737	Small molecule	75 mg	Oral

Indications