Galapagos and Gilead halt Phase III trials for idiopathic pulmonary fibrosis drug
pharmafile | February 11, 2021 | News story | | Gilead
Galapagos and Gilead have halted the ISABELA Phase III clinical studies for their autotaxin inhibitor ziritaxestat in patients with idiopathic pulmonary fibrosis (IPF).
The decision is based on the Independent Data Monitoring Committee (IDMC)’s recommendations which, following a regular review of unblinded data, concluded that ziritaxestat’s benefit-risk profile no longer supported the continuation of the studies.
The Phase III programme consists of two identically designed trials, ISABELA 1 & 2, aiming to enrol 1,500 IPF patients combined. Patients continued on their standard of care background treatment, and were randomised to receive either 200mg or 600mg ziritaxestat once daily or placebo. The primary endpoint was the rate of decline of forced vital capacity until week 52.
Dr Walid Abi-Saab, Chief Medical Officer at Galapagos, 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 would like to thank the patients and the medical professionals who participated in the ISABELA studies and contributed to the advancement of IPF research. We intend to learn from this data in our continued commitment to develop therapies in IPF and fibrosis.”
Onno van de Stolpe, CEO of Galapagos, added: “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.”
All clinical trials with ziritaxestat, including the long-term extension of the Phase IIa NOVESA trial in systemic sclerosis, will be discontinued.
Darcy Jimenez
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