Galapagos and Gilead Discontinue ISABELA Phase 3 Trials in IPF
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Investigators are being informed of the decision and they will be contacting their study participants to discontinue the investigational treatment.
The ISABELA Phase 3 program consists of two identically designed trials, ISABELA 1 & 2, aiming to enroll 1,500 IPF patients combined. Patients continued on their standard of care background treatment and were randomized on to either 200 mg or 600 mg ziritaxestat once daily or placebo. The primary endpoint was the rate of decline of forced vital capacity until week 52.
“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,” said Dr.
“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,” said
Ziritaxestat (GLPG1690) is an investigational autotaxin inhibitor discovered by Galapagos. Gilead in-licensed ex-European rights to ziritaxestat in
All clinical trials with ziritaxestat, including the long-term extension of the Phase 2a NOVESA trial in systemic sclerosis, will be discontinued.
This press release contains inside information within the meaning of Regulation (EU) No 596/2014 of the
Gilead Forward-Looking Statements
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the risk that Gilead may not realize any anticipated benefits from the collaborations with Galapagos; difficulties or unanticipated expenses in connection with the collaborations; the potential effects on Gilead's revenues and earnings; the ability of the companies to discover, develop and commercialize any products under the collaborations; the ability of the companies to initiate and complete clinical trials involving any product candidates under the collaborations in the currently anticipated timelines or at all; the possibility of unfavorable results from ongoing and additional clinical trials involving any product candidates under the collaborations; uncertainties relating to regulatory applications and related filing and approval timelines, the risk that any marketing approvals, if granted, may have significant limitations on its use; the possibility that the companies may make a strategic decision to discontinue development of involving any product candidates under the collaborations, and as a result, such products may never be successfully commercialized; and the accuracy of any assumptions underlying any of the foregoing. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s periodic reports filed with the
Galapagos Forward-Looking Statements
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks, uncertainties and other factors that could cause actual results to diﬀer materially from those referred to in the forward-looking statements and, therefore, the reader should not place undue reliance on them. These risks, uncertainties and other factors include, without limitation, the inherent risks associated with clinical trial and product development activities, competitive developments, and regulatory approval requirements, including the risk that data from the ongoing and planned clinical research programs with ziritaxestat may not support registration or further development due to safety, efficacy or other reasons for IPF, systemic sclerosis or any other indication, Galapagos’ reliance on collaborations with third parties, including the collaboration with Gilead for ziritaxestat, the uncertainty regarding estimates of the commercial potential of ziritaxestat, and the possibility that Galapagos and Gilead may make a strategic decision to discontinue development of ziritaxestat and that ziritaxestat may as a result never be successfully commercialized, as well as those risks and uncertainties identified in our Annual Report on Form 20-F for the year ended
Ziritaxestat is investigational; its efficacy and safety have not been fully evaluated by any regulatory authority and it is not yet approved for any use outside of clinical trials.
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