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.
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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. 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).
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 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.
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Gilead Jacquie Ross, Investors +1 (408) 656-8793
Arran Attridge, Media +1 (650) 425-8975
Galapagos Elizabeth Goodwin, Investors +1 781 460
1784
Sofie Van Gijsel, Investors +32 485 19 14 15 ir@glpg.com
Carmen Vroonen, Media +32 473 824 874
Anna Gibbins, Media +44 (0) 7717 801900
communications@glpg.com
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