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Galapagos, Gilead Sciences Pull Plug On Ziritaxestat Clinical Trials

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  • Galapagos NV (NASDAQ: GLPG) and Gilead Sciences Inc (NASDAQ: GILD) have decided to stop the ISABELA Phase 3 studies evaluating ziritaxestat in patients with idiopathic pulmonary fibrosis (IPF). All clinical trials with ziritaxestat, including the long-term extension of the Phase 2a NOVESA trial in systemic sclerosis, will be discontinued as well.

  • The decision is based on the Independent Data Monitoring Committee (IDMC) recommendations, 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 3 program consists of two identically designed trials, ISABELA 1 and ISABEL 2, aiming to enroll 1,500 IPF patients combined. Patients continued on their standard of care background treatment and were randomized 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.

  • Ziritaxestat (GLPG1690) is an investigational autotaxin inhibitor discovered by Galapagos. Gilead in-licensed ex-European rights to ziritaxestat in July 2019 and commenced sharing the Phase 3 development costs.

  • In September last year, Ziritaxestat reached the primary endpoint in the NOVESA trial in systemic sclerosis with a statistically significant change from baseline in the modified Rodnan Skin Score (mRSS) at Week 24, of -8.3 vs. -5.7 for placebo.  

  • Price Action: GLPG shares tanked 17.4% at $90.22, and GILD shares are up 0.12% at $67.38 on the last check Wednesday.

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