RARE Daily

Galapagos and Gilead Discontinue Late-Stage Study in IPF, Stop Development of Drug

February 10, 2021

Rare Daily Staff

Galapagos and Gilead Sciences said they have halted their late-stage study of the experimental therapy ziritaxestat in patients with idiopathic pulmonary fibrosis after an independent data monitoring committee concluded that based on a review of unblinded data, the benefit-risk profile no longer supported continuing these studies.

All clinical trials with ziritaxestat, including the long-term extension of the phase 2a NOVESA trial in systemic sclerosis, will be discontinued.

IPF is a serious, life-limiting lung disease characterized by fibrosis in the lungs, and this scar tissue accumulates until it reaches deadly levels. Replacement of normal lung tissue by fibrosis results in restriction in the ability to fill the lungs with air and decreased transfer of oxygen from inhaled air into the bloodstream resulting in lower oxygen delivery to the brain and other organs. Patients with IPF most often suffer from progressive shortness of breath, particularly with exertion; chronic cough; fatigue and weakness; and chest discomfort.

Ziritaxestat is an experimental autotaxin inhibitor discovered by Galapagos. Gilead in-licensed ex-European rights to ziritaxestat in July 2019 and commenced sharing the phase 3 development costs as part of a 10-year research and development collaboration. The deal provided Galapagos with a $3.95 billion upfront and an additional $1.1 billion equity investment.

The ISABELA phase 3 program consisted of two identically designed trials, ISABELA 1 and 2, aiming to enroll 1,500 IPF patients combined. Patients continued on their standard of care background treatment and were randomized 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.

“We are extremely disappointed by this news,” said Onno van de Stolpe, CEO of Galapagos. “Despite this setback, we remain committed to leveraging our novel target research engine and strong cash balance to discover potential therapies for IPF and fibrosis.”

Photo: Onno van de Stolpe, CEO of Galapagos

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