Gilead and Galapagos, who teamed up in a $5 billion deal in 2019, have suffered another major defeat. This week, the companies announced that they are halting a late-stage trial of ziritaxestat, an experimental treatment that was being investigated for idiopathic pulmonary fibrosis (IPF), a progressive lung disease.
The companies made the decision after an independent advisory committee reviewed data from the phase 3 trial and said the risk-benefit profile no longer supported running the study. A separate phase 2 trial studying the compound as a treatment for diffuse cutaneous system sclerosis is also being discontinued.
The news is the latest in a what has become a string of setbacks for the ill-fated duo. In December, Gilead handed the development rights of an anti-inflammatory drug, filgotinib, back to Galapagos after safety questions were raised. Although it won approval in Japan and the EU, the FDA rejected the drug for rheumatoid arthritis due to concerns over testicular toxicity. Convinced that they wouldn’t be able to sway the FDA, Gilead opted to not pursue U.S. approval and halted enrollment in trials for filgotinib for three other indications.
Despite the recent failure of ziritaxestat, Galapagos indicated that it will continue work on developing the treatment.
“We are extremely disappointed by this news. 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,” Onno van de Stolpe, CEO of Galapagos, said in a statement.
