The research, “Safety, tolerability, pharmacokinetics, and pharmacodynamics of GLPG1690, a novel autotaxin inhibitor, to treat idiopathic pulmonary fibrosis (FLORA): a phase 2a randomised placebo-controlled trial,” was published in the journal The Lancet Respiratory Medicine.
The company conducted the Phase 2 FLORA trial (NCT02738801) analyzing the safety, tolerability and pharmacological profile of a once-daily 600 mg dose of GLPG1690 in 23 IPF patients. The investigational oral therapy was given for 12 weeks to 17 patients; six patients received placebo.
Results revealed that, after 12 weeks, patients taking GLPG1690 had an increase of 8 mL in forced vital capacity (FVC), a measure of lung function, while those on placebo showed a reduction of 87 mL.
Treatment with GLPG1690 was well-tolerated, with most side effects being mild to moderate. No differences were observed between GLPG1690 and placebo regarding tolerability.
“Proof of concept studies are vital in addressing the huge unmet need for effective and well tolerated therapies for idiopathic pulmonary fibrosis,” Toby Maher, MD, PhD, the study’s lead author, said in a press release.
Considering the results “extremely encouraging,” Maher added that “studies such as FLORA quickly support proof-of-concept of new treatment options, without unnecessarily exposing high-risk patients to investigational therapies of unknown efficacy for prolonged periods of time.”
“Our findings support further development of GLPG1690 as a novel treatment for IPF,” the researchers wrote.
In addition to this publication, Galapagos is presented its research on GLPG1690 at the American Thoracic Society (ATS) 2018 meeting, which wraps up today in San Diego, California. At the meeting, Galapagos presented the following related abstracts:
- “Pharmacodynamics and Pharmacokinetics of the Autotaxin Inhibitor GLPG1690 in the FLORA Trial: a Randomized, Placebo-controlled, Double Blind Phase IIa Clinical Trial of 12 Weeks in Individuals with Idiopathic Pulmonary Fibrosis,” as a poster presentation on May 20;
- “A Randomized, Placebo-Controlled, Double Blind Phase IIa Clinical Trial to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of 12 Weeks of Treatment of an Autotaxin Inhibitor (GLPG1690) in Individuals with Idiopathic Pulmonary Fibrosis (FLORA Trial), as an oral presentation, also on May 20.
The company also had an oral presentation, “Assessment of the Effects of GLPG1690 in Idiopathic Pulmonary Disease (IPF) Patients Using Functional Respiratory Imaging (FRI),” on May 22, in which it showed that functional respiratory imaging is a sensitive tool for assessing IPF progression.
GLPG1690 is a small molecule therapy candidate that selectively blocks the autotaxin enzyme, which researchers believe is involved in development of fibrosis (scarring) and IPF progression.
In August 2017, Galapagos reported earlier results of the FLORA trial already showing that treatment with GLPG1690 prevented the decline in lung function.
The company received orphan drug designation for GLPG1690 from the U.S. Food & Drug Administration and the European Commission.
In April 2018, Galapagos announced the design of a global Phase 3 program called ISABELA to assess GLPG1690 in patients with IPF. This program intends to support both new drug application (NDA) and Market Authorization Application (MAA) filings in the U.S. and E.U., respectively.