GlobeNewswire

Galapagos and Gilead discontinue ISABELA Phase 3 trials in IPF

Share

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
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. For more information on Gilead Sciences, please visit the company’s website at www.gilead.com.

About Galapagos
Galapagos NV discovers and develops small molecule medicines with novel modes of action, several of which show promising patient results and are currently in late-stage development in multiple diseases. Our pipeline comprises discovery through Phase 3 programs in inflammation, fibrosis and other indications. Our ambition is to become a leading global biopharmaceutical company focused on the discovery, development and commercialization of innovative medicines. More information at www.glpg.com.

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).

Contacts Galapagos
Investors:Media:
Elizabeth Goodwin   Carmen Vroonen
VP IR  Global Head of Communications & Public Affairs
+1 781 460 1784  +32 473 824 874
Sofie Van Gijsel   Anna Gibbins
Senior Director IR     Senior Communications Director – Therapeutic Areas
+32 485 19 14 15    +44 (0) 7717 801900
ir@glpg.comcommunications@glpg.com
Contacts Gilead
Investors:Media:
Jacquie Ross Arran Attridge
+1 (408) 656-8793 +1 (650) 425-8975

Gilead Forward-Looking Statement
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 U.S.  Securities and Exchange Commission, including current reports on Form 8-K, quarterly reports on Form 10-Q and annual reports on Form 10-K. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

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.

Attachment


About GlobeNewswire

GlobeNewswire
GlobeNewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York

https://globenewswire.com

GlobeNewswire is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.

Subscribe to releases from GlobeNewswire

Subscribe to all the latest releases from GlobeNewswire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from GlobeNewswire

Introducing CorityOne™3.3.2021 19:00:00 CETPress release

Next-generation unified EHS and Quality platform empowers those who transform the way the world works Toronto, March 03, 2021 (GLOBE NEWSWIRE) -- Cority, the leading global enterprise EHS software provider, today announced a groundbreaking next-generation release of its true SaaS platform. CorityOne builds on a heritage of pragmatic innovation and is designed to help EHS and business leaders thrive beyond today to build stronger, more resilient, connected, and sustainable organizations that deliver on the promise of a better tomorrow. Recently recognized as a Leader in the Green Quadrant EHS Software 2021 by independent analyst firm, Verdantix, CorityOne brings together the most comprehensive Environmental, Health, Safety (EHS), and Quality management functionality to a common platform approach, unifying capabilities from acquired assets, including Enviance, and setting a new standard for the digital transformation of EHS and Quality. “It’s time to think differently about the future,” s

Bombardier and Aston Martin Announce Intent to Collaborate and Create the Ultimate Convergence of Performance and Style3.3.2021 18:00:00 CETPress release

Exclusive opportunity for Bombardier business aircraft customers to design their aircraft in collaboration with luxury British automotive manufacturer Initiative complements Bombardier’s established design leadership MONTREAL, March 03, 2021 (GLOBE NEWSWIRE) -- Aston Martin and Bombardier – two iconic brands – have signed a letter of intent to collaborate on custom design services for Bombardier business jets. The collaboration would give customers the opportunity for a truly unique design experience, with the meeting of the top creative minds from the luxury automotive and private jet industries. “Bombardier’s discerning customers have come to expect our products’ signature smooth ride and the company’s no-compromise approach to design, performance and reliability at every level of our portfolio,” said Peter Likoray, Senior Vice President, Sales and Marketing, New Aircraft, Bombardier. “We would be proud to add a new facet to this experience that channels Aston Martin’s distinct aesth

Eurocastle to Release Fourth Quarter 2020 Financial Results on 5 March 20213.3.2021 17:56:51 CETPress release

Contact: Oak Fund Services (Guernsey) Limited Company Administrator Attn: Mark Woodall Tel: +44 1481 723450 Eurocastle to Release Fourth Quarter 2020 Financial Results on 5 March 2021 ­­­ Guernsey, 3 March, 2021 – Eurocastle Investment Limited (“Eurocastle” or the “Company”) today announces that it will release its financial results for the twelve months ended 31 December 2020 on Friday, 5 March 2021 before the market opens. ABOUT EUROCASTLE Eurocastle Investment Limited (the “Company” or “Eurocastle”) is a publicly traded closed-ended investment company with investments focused on Italian performing and non-performing loans, Italian loan servicing platforms and other real estate related assets in Italy. On 18 November 2019, the Company announced a plan to realise the majority of its assets with the aim of accelerating the return of value to shareholders. The Company does not currently intend to seek new investments from the proceeds of the realisation but will continue to support its

SEK TENDER OPERATION ANNOUNCEMENT FOR ONWARD LENDING3.3.2021 16:20:00 CETPress release

Bid date, 2021-03-05Bid Submission Date2021-03-05Bid times10.30-11.00 (CET/CEST) on the Bid dateOffered Amount50 billion SEKMaximum Permitted Bid Volume12.5 billion SEK from an individual bidderSettlement Date2021-03-09Minimum Permitted Bid Volume10 million SEK per bidFinal Repayment Date2025-03-10Maximum Allocation25 per cent of Offered AmountAllocation TimeNot later than 11.30 (CET/CEST) on the Bid dateRepayment Date2022-03-09Option Repayment Date 12023-03-09Option Repayment Date 22024-03-11Interest rateThe Riksbank´s applicable repo rateAdditional interest rate0.10 per centConfirmation of bids to e-maileol@riksbank.se Stockholm, 2021-03-03 This is a translation of the special terms and conditions published on www.riksbank.se. In the case of any inconsistency between the English translation and the Swedish language version, the Swedish language version shall prevail. Complete terms and conditions can be retrieved at www.riksbank.se.

AERION, NETJETS AND FLIGHTSAFETY INTERNATIONAL TO EXPLORE FUTURE GLOBAL MOBILITY SOLUTIONS3.3.2021 16:03:23 CETPress release

Aerion® signs expansive Memorandum of Understanding (MOU) with NetJets and FlightSafety International® (FSI) to shape the future of global mobility NetJets and Aerion to explore exclusive partnership for the global mobility platform, Aerion ConnectTM FSI to support Aerion in establishing a new global Supersonic Training Academy NetJets has obtained purchase rights for 20 AS2® supersonic business jets, extending Aerion’s global order backlog to USD $10 billion+ ahead of 2023 production start Reno, NV & Columbus, OH, March 03, 2021 (GLOBE NEWSWIRE) -- Supersonic aircraft company Aerion, the leader in supersonic technology has forged an expansive collaboration with NetJets, the largest private aviation company in the world, and FlightSafety International, the leader in professional aviation training, — both Berkshire Hathaway companies — to shape the future of global mobility. “At Aerion our vision is to build a future where humanity can travel between any two points on our planet within

AT&T and other leading communications companies join the 25GS-PON Multi-Source Agreement (MSA) Group3.3.2021 15:00:00 CETPress release

The 25G symmetric PON multi-source agreement (25GS-PON MSA) Group is growing rapidly, with the addition of seven new members since it was first announcedAT&T’s commitment to the MSA Group highlights the importance of 25GS-PON to the telecommunications industryTechnology vendors including CommScope, Cortina Access, Feneck, HiLight Semiconductor, Hisense Broadband and Semtech among those fast-tracking 25GS-PON commercialization Industry group brings together major operators along with leading system and component vendors to define and promote next-generation 25GS-PON technology in support of emerging 5G and industrial requirements at cost-effective price targets March 3, 2021 The 25GS-PON MSA Group today announced the addition of seven new member companies including AT&T, CommScope, Cortina Access, Feneck, HiLight Semiconductor, Hisense Broadband and Semtech. These companies, along with the ten founding 25GS-PON MSA members, are enabling a move beyond the limitations of 10 Gb/s next-gene