Galapagos and Gilead discontinue ISABELA phase III trials of ziritaxestat in IPF.

Galapagos NV and Gilead Sciences announced the decision to halt the ISABELA Phase III clinical studies with the investigational autotaxin inhibitor ziritaxestat in patients with idiopathic pulmonary fibrosis. 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. The ISABELA Phase III program consists of two identically designed trials, ISABELA 1 & 2, aiming to enroll 1,500 IPF patients combined. Patients continued on their standard of care background treatment and were randomized on to either 200 mg or 600 mg ziritaxestat once daily or placebo. The primary endpoint was the rate of decline of forced vital capacity until week 52. All clinical trials with ziritaxestat, including the long-term extension of the Phase IIa NOVESA trial in systemic sclerosis, will be discontinued.