- First JAK-inhibitor to show efficacy in Crohn's
disease
- 48% clinical remission rate, statistically significant
versus placebo after 10 weeks induction therapy
- Significant improvements in clinical response and IBDQ
quality of life
- Filgotinib safety profile similar to that previously
observed
Webcast presentation of the results to be held
tomorrow 8 December, 16.00 CET/10 AM EDT/7 AM PDT, +1646 254 3373
access code 4725658 more call number info further down
Galapagos NV (Euronext:GLPG) (NASDAQ:GLPG) announced
today that 200 mg filgotinib is shown to be effective and safe as
once-daily, oral induction treatment in moderate to severe Crohn's
disease, based on the FITZROY phase 2 study at the 10-week interim
analysis. The study achieved the primary endpoint of clinical
remission: the percentage of patients achieving a CDAI score lower
than 150 was significantly higher in patients treated with
filgotinib versus patients receiving placebo. Filgotinib was
shown to be well tolerated in the FITZROY study, strengthening its
favorable safety profile.
175 patients with moderate to severe Crohn's
disease were enrolled in FITZROY, a double-blind,
placebo-controlled study. Patients recruited were either
anti-TNF naïve or anti-TNF failures. The full study has two
parts of 10 weeks each: the first part - reported today -
investigates the effect of filgotinib 200mg once daily versus
placebo as induction therapy. As the study is still ongoing,
individual data remain blinded. Galapagos expects to report
the full 20 week results for FITZROY in the first half of 2016.
Summary of clinical key endpoints after interim
analysis at 10 weeks:
|
placebo n=44 |
filgotinib 200mg n=128 |
p-value |
Clinical remission (CDAI lower than 150) (%), ITT-NRI |
23 |
48 |
0.0067 |
Clinical response, (CDAI decrease 100 points or more) (%),
ITT-NRI |
41 |
60 |
0.0386 |
Total IBDQ score, mean change from baseline, ITT-LOCF |
17.56 |
33.82 |
0.0045 |
Overall, in the FITZROY study, filgotinib
demonstrated a favorable safety profile consistent with the
previous DARWIN studies. Similar incidences in SAEs and AEs
were observed between filgotinib and placebo, with the majority of
the SAEs related to worsening of Crohn's disease. In the
FITZROY study, filgotinib showed a favorable lipid profile with an
increase in HDL and no change in LDL, resulting in an improved
atherogenic index. An increase in hemoglobin was also
observed in FITZROY, without difference between filgotinib and
placebo. No clinically significant changes from baseline in
neutrophils or liver function tests were observed in this
study.
"These data are robust and important because
collectively they show that patients who received filgotinib had
higher rates of clinical remission and their quality of life
improved considerably. This was further accompanied by a
significant proportion of patients normalizing their CRP, an
objective biomarker of inflammation," commented principal
investigator Dr Séverine Vermeire, Department of Gastroenterology,
University hospitals Leuven. "It is also important to note that
during the first 10 weeks of dosing no unexpected safety findings
emerged."
"The results of this study are exciting and show
that with an oral treatment and new mechanism of action we are able
to induce a high rate of clinical remission in moderate to severe
Crohn's disease patients. Taken together with a favorable safety
profile, filgotinib has a good potential as future treatment for
IBD," added Dr William Sandborn, Chief, Division of
Gastroenterology, University of California San Diego School of
Medicine.
"Filgotinib is the first JAK inhibitor to show
efficacy in Crohn's disease, a disease with still few treatment
options today," said Piet Wigerinck, CSO of Galapagos. "These
favorable FITZROY study results complement the excellent DARWIN
data in rheumatoid arthritis and open up new opportunities in
a broader range of inflammatory diseases for filgotinib, our
selective JAK-1 inhibitor."
"We are proud to bring innovative treatments to
patients where high unmet medical need exists. We intend to
move this drug to Phase 3 as soon as possible," said Onno van de
Stolpe, CEO of Galapagos. "Once again, Galapagos has
demonstrated that its technology platform has the potential to
deliver safe and efficacious drugs which actually can modify the
disease for patients. Our pipeline is filling with later
stage programs based on the same approach we used to discover and
develop filgotinib."
Conference call and webcast
presentation
Galapagos will conduct a conference call open to
the public tomorrow, 8 December 2015, at 16:00 CET/10 AM EDT/8 AM
PDT, which will also be webcasted. To participate in the
conference call, please call one of the following numbers ten
minutes prior to commencement:
|
Confirmation Code: |
4725658 |
|
United Kingdom: |
+44(0)20 3427 1928 |
|
France: |
+33(0)1 76 77 22 40 |
|
Toll free France: |
0805 636 390 |
|
Belgium: |
+32(0)2 400 1974 |
|
Toll free Belgium: |
0800 39271 |
|
United States of America: |
+1646 254 3373 |
|
Netherlands: |
+31(0)20 721 9157 |
|
Toll free Netherlands: |
8000 222 330 |
|
Toll free United Kingdom: |
0800 279 4849 |
|
Toll free phone United States of America: |
1855 217 7942 |
A question and answer session will follow the
presentation of the results. Go to www.glpg.com to access the
live audio webcast. The archived webcast, PDF of the slides,
and a transcript will also be available on the Galapagos website
later in the day.
About the study endpoints: CDAI, IBDQ
The Crohn's Disease Activity Index (CDAI)
incorporates disease activity indicators in the form of a patient
diary. The composite CDAI score is calculated based on 8 elements
with various weightings: number of liquid or soft stools each day
for 7 days, abdominal pain each day for 7 days, general well-being
for 7 days, presence of complications, taking
diphenoxylate/atropine, loperamide, or opiates for diarrhea,
presence of an abdominal mass, hematocrit of lower than 0.47 in men
and lower tha 0.42 in women, and percentage deviation from standard
weight. Clinical remission is defined as CDAI score lower
than 150, while clinical response involves a decrease in CDAI of
100 points or more. Disease states are defined as mild: 150
to 220, moderate to severe: 220 to 450, and severe: more than 450
(adapted from AGA Perspectives, Vol. 9 No. 2, April/May 2013).
The Inflammatory Bowel Disease Questionnaire
(IBDQ) is a questionnaire for health-related quality of life
assessment in patients with inflammatory bowel diseases: ulcerative
colitis and Crohn's disease. It consists of 32 questions
divided into four groups: bowel symptoms (10 items), systemic
symptoms (5 items), emotional function (12 items) and social
function (5 items). Every question has graded responses from
1 to 7, and thus the total score is ranging from 32 to 224 with
higher scores representing better quality of life. The IBDQ
is a validated assessment tool that reflects important changes in
the quality of life of patients with IBD (adapted from Pallis et
al, Inflamm Bowel Dis, Volume 10, Number 3, May 2004).
About filgotinib
Filgotinib is a highly selective JAK1 inhibitor
discovered and developed by Galapagos using its target and drug
discovery technology platform. In more than 700 patient years
of rheumatoid arthritis (RA) clinical study experience, filgotinib
has shown a rapid onset of action, potentially best-in-class
efficacy and to be safe and well tolerated in these studies. The
Company is preparing to initiate a Phase 3 program with filgotinib
in rheumatoid arthritis in the first half of 2016. Filgotinib
is fully proprietary to Galapagos.
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 stop the inflammation in the
intestine, prevent flare-ups 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.
Anti-TNF agents have also demonstrated side effects arising
from long term suppression of the immune system including increased
rate of infections. Unlike in RA, few biologics have been
approved in CD and, as such, caregivers have a more limited number
of available treatments. The market for CD therapies, across
the 10 main healthcare markets, was approximately $3.2 billion in
2012 and is estimated to exceed $4.1 billion in 2022, according to
a January 2014 GlobalData PharmaPoint report, driven primarily by
use of anti-TNF agents.
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 three phase 2, three phase 1, five pre-clinical
and 20 discovery studies in cystic fibrosis, inflammation,
fibrosis, osteoarthritis and other indications. We are
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 400
employees, operating from its Mechelen, Belgium headquarters and
facilities in The Netherlands, France, and Croatia. More
information at www.glpg.com.
Contacts
Galapagos NV
Investors: Media:
Elizabeth
Goodwin Evelyn
Fox VP IR & Corporate
Communications Director
Communications +1 781 460
1784 +31
6 53 591 999
ir@glpg.com communications@glpg.com
Galapagos forward-looking statements This release may
contain forward-looking statements, including, among other things,
statements regarding the mechanism of action and profile, and
timing of clinical trials and results, of filgotinib.
Galapagos cautions the reader that forward-looking statements are
not guarantees of future performance. In particular it should
be noted that the positive interim results of the FITZROY phase 2
trial with filgotinib in Crohn's disease may not be indicative of
future results. 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 filgotinib development
program may be incorrect, the inherent uncertainties associated
with competitive developments, clinical trial and product
development activities and regulatory approval requirements
(including that data from Galapagos' ongoing clinical research
programs may not support registration or further development of its
drug candidates due to safety, efficacy or other reasons),
Galapagos' reliance on collaborations with third parties, 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' prospectus filed with the SEC on 14 May 2015 and future
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.
Filgotinib meets primairy endpoint in phase 2 study in Crohn's
disease http://hugin.info/133350/R/1972012/721188.pdf
HUG#1972012
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