Galapagos, Gilead Halt Trials of Lung-Disease Treatment
(Bloomberg) -- Galapagos NV and Gilead Sciences Inc. are stopping late-stage clinical trials of an experimental treatment for a progressive lung disease following a recommendation by the study’s independent monitors.
A data monitoring committee concluded the risk-benefit profile of the experimental drug, ziritaxestat, no longer supports continuing the studies in idiopathic pulmonary fibrosis, the drugmakers said Wednesday in a statement.
The two companies have been partners since 2015, with Gilead agreeing to pay $5.1 billion to raise its stake in the Belgian company in 2019 to gain rights to drugs in development. Galapagos suffered another disappointment in December when Gilead dropped its pursuit of U.S. approval for Jyseleca as a treatment for rheumatoid arthritis. The drug has clearance for that use in Europe.
Ziritaxestat is an inhibitor of a biochemical called autotaxin that’s involved with fibrosis, a progressive condition involving scarring of tissues that’s often irreversible. Galapagos’s most advanced drug candidate, it has orphan designation in the U.S. and European Union that’s granted to help speed regulatory review.
The data monitoring committee determined in its sixth meeting that the trials should be halted, said Elizabeth Goodwin, a Galapagos spokeswoman, declining to give further reasons for the discontinuation.
Idiopathic pulmonary fibrosis affects about 100,000 people in the U.S., according to the National Institutes of Health. The drug had earlier shown promise in a mid-stage study of the lung condition.
The late-stage study consisted of two trials that had aimed to enroll 1,500 patients. Studies of the same compound in another condition, diffuse cutaneous system sclerosis, will also be discontinued, the companies said.
Galapagos shares traded in Amsterdam fell 19%, the most since August. Gilead was little changed in New York.
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