Maher TM, et al. - Researchers evaluated the impacts of GLPG1690 [(Galapagos, Mechelen, Belgiuma) a novel, potent, selective autotaxin inhibitor with good oral exposure] in patients with idiopathic pulmonary fibrosis (IPF). The further development of GLPG1690 as a novel treatment for IPF was supported in the findings.

Methods

• Experts conducted a randomised, double-blind, placebo-controlled phase 2a study in 17 centres in Italy, Ukraine and the UK.
• The patients eligible for this study were aged 40 years or older, non-smokers, not taking pirfenidone or nintedanib, and had a centrally confirmed diagnosis of IPF.
• They used a computer-generated randomisation schedule to assign patients 1:3 to receive placebo or 600 mg oral GLPG1690 once daily for 12 weeks.
• Safety (adverse events), tolerability, pharmacokinetics, and pharmacodynamics were the primary outcomes.
• They assessed the spirometry as a secondary outcome.

Results

• Findings suggested that between March 24, 2016, and May 2, 2017, screeening of 72 patients was done, of whom 49 were ineligible and 23 were enrolled in 8 centres (6 in Ukraine and 2 in the UK).
• As per data, 6 patients were assigned to receive placebo and 17 to receive GLPG1690.
• The study was completed by 20 patients after 1 in each group discontinued because of adverse events and 1 in the GLPG1690 group withdrew consent.
• Results demonstrated that 4 (67%) patients in the placebo group and 11 (65%) in the GLPG1690 group had treatment-emergent adverse events, most of which were mild to moderate.
• Infections and infestations (ten events) and respiratory, thoracic, and mediastinal disorders (eight events) were the most frequent events in the GLPG1690 group with no apparent differences from the placebo group.
• Events that were judged to be related to treatment were seen in 2 (12%) patients in the GLPG1690 group.
• Two patients in the placebo group (1 had a urinary tract infection, acute kidney injury, and lower respiratory tract infection and the other had atrioventricular block, second degree) and 1 in the GLPG1690 group (cholangiocarcinoma that resulted in discontinuation of treatment) demonstrated the serious adverse events.
• None of the patients died.
• They noted similar pharmacokinetic and pharmacodynamic profiles of GLPG1690 to those previously shown in healthy controls.
• They noted a consistent decrease in the LPA C18:2 concentrations in plasma .
• At week 12, the mean change from baseline in forced vital capacity was 25 mL (95% CI -75 to 124) for GLPG1690 and -70 mL (-208 to 68 mL) for placebo.