Galapagos reports additional data with filgotinib from the Phase 2 FITZROY study
April 21 2016 - 4:03PM
- Filgotinib: an investigational JAK-inhibitor shows efficacy
in Crohn's disease
- Clinical responses continued from week 10 to week
20
- Safety profile similar to that previously observed
- Phase 3 program in Crohn's disease to be initiated in
2016
Galapagos NV (Euronext & NASDAQ: GLPG) reported 20-week
results from its FITZROY study with the investigational, selective
JAK1 inhibitor filgotinib in Crohn's disease.
174 patients with moderately to severely active
Crohn's disease were enrolled in FITZROY, a double-blind,
placebo-controlled Phase 2 study. Patients recruited were
either anti-TNF naïve or anti-TNF failures. The study
comprised two parts each of 10 weeks duration: the first part -
reported in December 2015 - investigated the safety and efficacy of
filgotinib 200 mg once daily versus placebo. The FITZROY
study achieved the primary endpoint of clinical remission at 10
weeks: the percentage of patients achieving a Crohn's Disease
Activity Index (CDAI) score lower than 150 was significantly higher
in patients treated with filgotinib versus patients receiving
placebo. Improvement in histopathology and endoscopy
assessments were observed at Week 10. Further evaluation is
ongoing.
The second part of the study investigated
continued treatment through 20 weeks in an exploratory analysis
that was not powered for statistical significance. Clinical
responses continued from week 10 to week 20. Non-responders
in the placebo arm from the first ten weeks received filgotinib
100 mg in the second ten weeks and showed improvement in
clinical remission during the second part of the study.
There were no new safety signals during the
second part of the FITZROY study, consistent with the profile of
filgotinib previously described. Most common adverse events
observed during this study were infections, gastrointestinal
disorders and nervous system disorders. There were no
gastrointestinal perforations, no cancers and no deaths reported
during the study.
Galapagos and Gilead Sciences intend to submit
the FITZROY 20-week results to future medical conferences.
"We are pleased by the outcome of the FITZROY
study, positioning filgotinib as a potential oral treatment for
patients with Crohn's disease. The observed safety profile of
filgotinib further strengthens its promising efficacy," said Piet
Wigerinck, Chief Scientific Officer at Galapagos. "We are
proud to be advancing what could become the first new oral
treatment for Crohn's disease in decades."
Galapagos and Gilead entered into a global
partnership for the development and commercialization of filgotinib
for inflammatory indications. Gilead intends to initiate a
Phase 3 study with filgotinib in Crohn's disease later in
2016.
About Crohn's disease Crohn's disease (CD) is an
inflammatory bowel disease causing chronic inflammation of the
gastrointestinal, or GI, tract with a relapsing and remitting
course. The prevalence estimates for CD in North America
range from 44 cases to 201 cases per 100,000 persons and in Europe,
from 37.5 cases to 238 cases per 100,000 persons. The disease
is slightly more common in women, with a peak incidence at the age
of 20 to 40 years. The disease is characterized by
inflammation that may affect any part of the GI tract from mouth to
anus, but most commonly the distal small intestine and proximal
colon, causing a wide variety of symptoms including anemia,
abdominal pain, diarrhea, vomiting, and weight loss. The
characteristic inflammatory response of CD is focal transmural
inflammation, frequently associated with granuloma formation, which
may evolve to progressive damage over time. Treatment of CD
will depend on severity of the disease. The main goal of
treatment is to reduce inflammation in the intestine, prevent
flares and keep patients' disease in remission. While mild
symptoms may respond to an antidiarrheal medicine, antibiotics, and
other medicines to control inflammation, severe symptoms are often
treated with anti-TNF agents. Anti-TNF agents, however, do
not work for all patients, and, in patients who do find therapeutic
benefit, they can lose their effect over time as a result of
relapse.
About filgotinib Filgotinib is an
investigational, selective JAK1 inhibitor discovered and developed
by Galapagos using its target and drug discovery technology
platform. In addition to the promising efficacy and safety
with filgotinib in Crohn's disease, filgotinib has also been
studied in rheumatoid arthritis (RA) with over 700 patient years of
experience. Galapagos and Gilead have a global partnership
for the development and commercialization of filgotinib for
inflammatory indications. Gilead is preparing to initiate a
Phase 3 program with filgotinib in RA and Crohn's disease in
2016.
About Galapagos Galapagos (Euronext & NASDAQ: GLPG)
is a clinical-stage biotechnology company specialized in the
discovery and development of small molecule medicines with novel
modes of action. Our pipeline comprises a maturing pipeline
of Phase 2, Phase 1, pre-clinical, and discovery programs in cystic
fibrosis, inflammation, fibrosis, osteoarthritis and other
indications. We have discovered and developed filgotinib: in
collaboration with Gilead we aim to bring this JAK1-selective
inhibitor for inflammatory indications to patients all over the
world. Galapagos is focused on the development and
commercialization of novel medicines that will improve people's
lives. The Galapagos group, including fee-for-service
subsidiary Fidelta, has approximately 440 employees, operating from
its Mechelen, Belgium headquarters and facilities in The
Netherlands, France, and Croatia. More information at
www.glpg.com.
Contacts
Investors: |
Media: |
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Evelyn
Fox |
VP IR &
Corp Communications +1 781 460 1784 |
Director
Communications +31 6 53 591 999 |
Paul van der Horst Director IR & Business Development +31 6 53
725 199 |
communications@glpg.com
|
ir@glpg.com |
|
Galapagos Forward-Looking Statements This release may
contain forward-looking statements, including statements regarding
any guidance given by Galapagos' management, the anticipated timing
of clinical studies with filgotinib and the progression and results
of such studies. Galapagos cautions the reader that
forward-looking statements are not guarantees of future
performance. Forward-looking statements involve known and
unknown risks, uncertainties and other factors which might cause
the actual results, financial condition and liquidity, performance
or achievements of Galapagos, or industry results, to be materially
different from any historic or future results, financial conditions
and liquidity, performance or achievements expressed or implied by
such forward-looking statements. In addition, even if
Galapagos' results, performance, financial condition and liquidity,
and the development of the industry in which it operates are
consistent with such forward-looking statements, they may not be
predictive of results or developments in future periods.
Among the factors that may result in differences are that
Galapagos' expectations regarding its the inherent
uncertainties associated with competitive developments, clinical
trial and product development activities and regulatory approval
requirements, Galapagos' reliance on collaborations with third
parties (including its collaboration partner for filgotinib,
Gilead), and estimating the commercial potential of Galapagos'
product candidates. A further list and description of these
risks, uncertainties and other risks can be found in Galapagos'
Securities and Exchange Commission (SEC) filings and reports,
including in Galapagos' most recent annual report on form 20-F
filed with the SEC and subsequent filings and reports filed by
Galapagos with the SEC. Given these uncertainties, the reader
is advised not to place any undue reliance on such forward-looking
statements. These forward-looking statements speak only as of
the date of publication of this document. Galapagos expressly
disclaims any obligation to update any such forward-looking
statements in this document to reflect any change in its
expectations with regard thereto or any change in events,
conditions or circumstances on which any such statement is based or
that may affect the likelihood that actual results will differ from
those set forth in the forward-looking statements, unless
specifically required by law or regulation.
GLGP reports additional data from Phase 2 FITZROY study
http://hugin.info/133350/R/2005809/741005.pdf
HUG#2005809
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