Galapagos and Gilead have halted the phase 3 ISABELA program, consisting of two studies evaluating ziritaxestat in patients with idiopathic pulmonary fibrosis (IPF). The decision is based on the recommendations of the Independent Data Monitoring Committee (IDMC) which, following a regular review of unblinded data, concluded that ziritaxestat’s benefit-risk profile no longer supported continuing these studies. Detailed data of the ISABELA studies will be presented at future medical meetings.
Investigators are being informed of the decision and they will be contacting their study participants to discontinue the investigational treatment.
The program includes ISABELA 1 and ISABELA 2, identically designed trials aiming to enroll 1,500 IPF patients combined. Patients continued on their standard of care background treatment and were randomized on to either 200mg or 600mg ziritaxestat once daily or placebo. The primary endpoint was the rate of decline of forced vital capacity until week 52.
“We are very disappointed not to be able to bring a novel medication to patients suffering from such a devastating disease with high unmet need. We would like to thank the patients and the medical professionals who participated in the ISABELA studies and contributed to the advancement of IPF research. We intend to learn from this data in our continued commitment to develop therapies in IPF and fibrosis,” said Dr. Walid Abi-Saab, Chief Medical Officer of Galapagos.
Gilead and Galapagos entered into a global (excluding Europe) collaborative agreement in July of 2019, whereby Gilead gained access to a portfolio of compounds, including six molecules currently in clinical trials, more than 20 preclinical programs and a proven drug discovery platform.
About Ziritaxestat (GLPG1690)
Ziritaxestat (GLPG1690) is an oral, once daily autotaxin inhibitor. Autotaxin has been implicated in various physiological and pathophysiological processes, including vascular and neural development, lymphocyte trafficking, fibrosis and tumor progression.
About idiopathic pulmonary fibrosis (IPF)
IPF is a type of lung disease that results in scarring (fibrosis) of the lungs for an unknown reason. Over time, the scarring gets worse and it becomes hard to take in a deep breath and the lungs cannot take in enough oxygen.