Galapagos and Gilead discontinue ISABELA Phase 3 trials in IPF
February 10 2021 - 9:00AM
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 SciencesGilead 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 GalapagosGalapagos 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.com |
communications@glpg.com |
|
|
Contacts Gilead |
|
Investors: |
Media: |
Jacquie Ross |
Arran Attridge |
+1 (408) 656-8793 |
+1 (650) 425-8975 |
Gilead Forward-Looking StatementThis
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.
Galapagos (EU:GLPG)
Historical Stock Chart
From Sep 2024 to Oct 2024
Galapagos (EU:GLPG)
Historical Stock Chart
From Oct 2023 to Oct 2024