Date: 2016-04-06
Type of information: Initiation of the trial
phase: 2a
Announcement: initiation of the trial
Company: Galapagos (Belgium)
Product: GLPG1690
Action
mechanism: enzyme inhibitor/autotaxin inhibitor. GLPG1690 has a novel mode of action discovered by Galapagos, with potential application in pulmonary diseases. Galapagos identified autotaxin as playing a key role in inflammation, using an inflammation assay in its unique target discovery platform. Pharmacology and translational studies published by other parties in the literature since then suggest autotaxin may play a key role in metabolic disease, arthritic pain, oncology, and lung disease. In 2007, Galapagos announced an alliance agreement with Janssen Pharmaceutica NV providing the option to worldwide, commercial licenses to certain Galapagos internal inflammatory disease programs. These programs are based on novel targets for inflammatory disorders that were identified and validated by Galapagos using its proprietary target discovery engine. Subsequent Galapagos research led to the discovery of GLPG1690, a first-in-class molecule that entered the clinic for inflammatory disorders. Galapagos is responsible for execution of Phase 1 and Phase 2A studies with GLPG1690. Janssen Pharmaceutica NV and Galapagos have mutually agreed to terminate these inflammation alliance and option agreements in March 2015.
Disease: idiopathic pulmonary fibrosis
Therapeutic area: Lung diseases - Respiratory diseases - Rare diseases
Country:
Trial details:
Latest
news: * On April 6, 2016, Galapagos announced the start of its exploratory Phase 2a study with GLPG1690 in idiopathic pulmonary fibrosis (IPF) patients, named FLORA. This randomized, double-blind, placebo-controlled study will investigate a once daily oral dose of GLPG1690 administered for 12 weeks in 24 IPF patients. Primary objectives of the study are to assess safety, tolerability, pharmacokinetics and pharmacodynamics of GLPG1690 in an IPF patient population. Target engagement will be measured by LPA in plasma and bronchoalveolar lavage fluid, both at baseline and through twelve weeks of treatment. Secondary objectives include the evaluation of lung function, changes in disease biomarkers and quality of life. Galapagos expects to complete patient recruitment before end 2016, and to report topline results in Q2 2017.
