Another blow for Galapagos and Gilead as ziritaxestat fails in Phase III IPF trial

Late yesterday, Galapagos and Gilead announced the decision to halt the ISABELA Phase III clinical studies with the investigational autotaxin inhibitor ziritaxestat in patients with idiopathic pulmonary fibrosis (IPF). All clinical trials with ziritaxestat, including the long-term extension of the Phase IIa NOVESA trial in systemic sclerosis, will be discontinued.

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.

Back in 2019, Gilead expanded its collaboration with Galapagos, to secure rights to a range of developmental candidates from the Belgian firm, that involved an investment of more than $5 billion, including an upfront $3.95 billion.