- Galapagos NV (NASDAQ:GLPG) announces the design of its registrational Phase 3 program for GLPG1690 in ideopathic pulmonary fibrosis (IPF).
- Two identical pivotal trials, ISABELA 1 and ISABELA 2, will evaluate GLPG1690 in ~1,500 IPF patients whether or not they have been previously treated with Roche's Esbriet (pirfenidone) or Boehringer Ingelheim's Ofev (nintedanib). The primary endpoint will be the rate of decline of forced vital capacity (FVC), a measure of lung function, until week 52. Dosing should commence in H2.
- GLPG1690 is a small molecule inhibitor of autotaxin, an enzyme that is up-regulated in many inflammatory conditions, including fibrosis.
- IPF is a progressive disorder that typically strikes adults over the age of 40. The prognosis is poor, with median survival of only 2-5 years. Ideopathic means that the cause of the disease is unknown.
- Previously: Galapagos' IPF candidate GLPG1690 halts disease progression in mid-stage study; shares ahead 22% premarket (Aug. 10, 2017)