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Galapagos and Gilead Sciences to halt Phase III IPF trials

Galapagos and Gilead Sciences have announced the decision to discontinue the ISABELA Phase III clinical studies of ziritaxestat (GLPG1690) in patients with idiopathic pulmonary fibrosis (IPF).

Discovered by Galapagos, ziritaxestat is an investigational autotaxin inhibitor. In July 2019, Gilead in-licensed ex-European rights to ziritaxestat and began sharing the Phase III development costs.

The latest move is based on the recommendation by the Independent Data Monitoring Committee (IDMC). Following a regular review of unblinded data, the committee noted that ziritaxestat’s benefit-risk profile no longer supported the continuation of these studies.

Galapagos chief medical officer Dr Walid Abi-Saab said: “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 intend to learn from this data in our continued commitment to developing therapies in IPF and fibrosis.”

Investigators are being notified of the discontinuation of the studies and the participants will be informed to stop the investigational treatment.

The ISABELA Phase III programme has two trials that have been identically designed: ISABELA 1 & 2, intending to enrol a total of 1,500 IPF patients.

Patients continued on their standard of care background treatment and randomly received either a once-daily dose of ziritaxestat 200mg or 600mg or placebo.

11th February 2021

https://www.clinicaltrialsarena.com/

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