Galapagos and Gilead discontinue ISABELA Phase 3 trials in IPF
February 10, 2021 at 09:00 AM EST
Foster City, CA and Mechelen, Belgium, 10 February 2021, 15.00 CET; regulated information – Galapagos NV (Euronext & NASDAQ: GLPG) and Gilead Sciences (NASDAQ: GILD) today announced the decision to halt the ISABELA Phase 3 clinical studies with the investigational autotaxin inhibitor ziritaxestat in patients with idiopathic pulmonary fibrosis. The decision is based on the recommendations of the Independent Data Monitoring Committee (IDMC) 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.
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 200mg or 600mg 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. Walid Abi-Saab, Chief Medical Officer of Galapagos.
“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 Onno van de Stolpe, CEO of Galapagos.
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.
All clinical trials with ziritaxestat, including the long-term extension of the Phase 2a NOVESA trial in systemic sclerosis, will be discontinued.
About Gilead Sciences
This press release contains inside information within the meaning of Regulation (EU) No 596/2014 of the European Parliament and of the Council of 16 April 2014 on market abuse (market abuse regulation).
Gilead Forward-Looking Statement
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 31 December 2019 and our subsequent filings with the SEC. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The forward-looking statements contained herein are based on management’s current expectations and beliefs and speak only as of the date hereof, and Galapagos makes no commitment to update or publicly release any revisions to forward-looking statements in order to reflect new information or subsequent events, circumstances or changes in expectations.
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.