-
ACR20 scores up to 73%
as once-daily monotherapy at
12 weeks
-
Statistically significant ACR20
and ACR50 responses at all dose levels
-
Onset of efficacy within first
week of treatment in this trial
-
Safety profile in DARWIN 2
consistent with previous filgotinib RA studies
Webcast presentation
of the results to be held on 28 April 2015, 16.00 CET/10 AM EDT/ 8
AM PDT, +32 2 620 0138,
access code 6206795,
more call number info further
down
Mechelen,
Belgium; 27 April 2015: Galapagos NV (Euronext: GLPG)
announced today that the selective JAK1 inhibitor
filgotinib as once-daily monotherapy showed rapid improvements in
signs and symptoms of moderately severe, active rheumatoid
arthritis (RA) and met key efficacy endpoints after 12 weeks of
treatment in the DARWIN 2 Phase 2B study. The study achieved
its primary endpoint at all doses and demonstrated statistically
significant improvements in ACR20 response versus placebo after 12
weeks of treatment. In addition, statistically significant
ACR50 response and DAS28(CRP) decrease were achieved with all dose
levels. Filgotinib was well tolerated in this study.
Hemoglobin levels increased. These first 12 week results in
the ongoing 24 week study are consistent with the efficacy and
safety profile of filgotinib observed in prior clinical studies.
DARWIN 2 is an ongoing, 24 week,
double-blind, placebo-controlled evaluation of filgotinib, as
once-daily administration (QD dosing) at 3 dose levels. Results
were reported for 283 patients with moderate to severe rheumatoid
arthritis who showed an inadequate response to methotrexate.
Filgotinib or placebo was given as monotherapy. The patients were
evaluated up to 12 weeks, the time of the primary endpoint of the
study. Galapagos expects to report the full 24 week results
for DARWIN 2 in the 3rd quarter of
this year.
Summary of the ACR responses and
DAS28(CRP) changes at 12 weeks of once-daily monotherapy:
|
Placebo
n=72 |
50
mg
n=72 |
100
mg
n=70 |
200
mg
n=69 |
ACR20 responders,
NRI, % |
31 |
67*** |
66*** |
73*** |
ACR50 responders,
NRI, % |
11 |
36** |
34** |
44*** |
ACR70 responders,
NRI, % |
4 |
8 |
19* |
13 |
DAS28(CRP),
LOCF, mean change from baseline |
-1.0 |
-1.7*** |
-2.0*** |
-2.3*** |
* p< 0.05 vs. placebo; **
p<0.01 vs. placebo; *** p<0.001 vs. placebo
ACR responses based on intent to treat (ITT) analysis, with
non-responder imputation (NRI).
Mean baseline DAS28(CRP) varied between 6.0 and 6.2. The DAS28(CRP)
is analyzed by ITT with last observation carried forward
(LOCF).
The results from this study show a
rapid onset of efficacy, with ACR20 response, investigator's
assessment of disease and patient-reported improvements (global
assessment of disease and pain) reaching statistical significance
after one week of treatment.
Over all dose groups including
placebo, 1.8% of patients stopped treatment during the study for
safety reasons. Within this low number of discontinuations, the
distribution across treatment groups is not disclosed to avoid
individual treatment unblinding while the study is ongoing.
Serious (2% overall) and non-serious treatment-emergent
adverse events overall were evenly spread over the dose groups
including placebo. Infections and infestations were the most common
(15% for filgotinib vs 10% for placebo), with only 2 (0.7%) serious
infections which remain blinded for the treatment group.
Consistent with its selective JAK1 inhibition, filgotinib treatment
led to a dose-dependent improvement in hemoglobin (up to 0.4 g/dL,
or 3.4% increase from baseline). A decline in
neutrophils, consistent with anti-inflammatory activity, was
observed during the first 4 weeks, with stable levels in the normal
range thereafter. No discontinuations due to anemia,
neutropenia, or increase in transaminases were reported.
Dose-dependent, well-balanced increases in LDL and HDL were
observed.
"The results from the DARWIN 2
study are truly exciting, with consistent efficacy meeting key
endpoints across the different geographical regions. If
confirmed in longer-term studies, selective inhibition of JAK1 by
filgotinib may lead to a differentiated safety profile without
compromising efficacy," said Professor Arthur Kavanaugh, MD,
Professor of Medicine at the University of California, San Diego
(UCSD) School of Medicine, and Principal Investigator for DARWIN
2.
"Once-daily monotherapy in DARWIN
2 led to similar efficacy as that observed at the high doses in
DARWIN 1, where patients took once- or twice-daily filgotinib with
methotrexate. And we found the same fast onset of
action. These data support our belief that filgotinib could
be used prior to initiating anti-TNF therapy," said Dr Piet
Wigerinck, Chief Scientific Officer of Galapagos. "Selective
inhibition of JAK1 increases hemoglobin, which is important to
improve the patient's fatigue and thereby overall condition.
These 12-week monotherapy results in RA further support our belief
that filgotinib has a promising future to address a significant
medical need. We look forward to the final 24 week data for
both DARWIN 1 and 2, later this year."
About the DARWIN
2 trial and its measures
The primary endpoint of the DARWIN 2 study is efficacy in terms of
percentage of subjects achieving an ACR20 response after 12 weeks
of treatment. In accordance with the protocol for the DARWIN
2 study, at week 12, all subjects on placebo and those who received
50 mg once-daily filgotinib but did not achieve a 20% improvement
in swollen joint count and tender joint count have been
re-randomized to a 100 mg once-daily dose. Other subjects
will maintain their randomized treatment until week 24.
Secondary trial objectives include efficacy in terms of the
percentage of subjects achieving an ACR20 response at week 24,
ACR50 and ACR70 response and other disease activity measures, as
well as safety and tolerability and effects on fatigue and quality
of life.
The improvement of rheumatoid
arthritis can be assessed using composite scores as recommended by
the American College of Rheumatology, or ACR. The ACR
criteria measure improvement in tender and swollen joint counts and
include other parameters which take into account the patient's and
physician's assessment of disease, pain, and an anti-inflammatory
biomarker. These clinical and laboratory disease activity
parameters are combined to form a composite score and are expressed
as percentages of clinical response that are known as ACR20, ACR50,
and ACR70. An ACR20 score represents at least a 20% improvement in
these criteria and is considered a modest improvement in a
patient's disease. An ACR50 and ACR70 represent a minimal 50% and
70% improvement in the response criteria, respectively, and each is
considered evidence of a substantial improvement in a patient's
disease.
The DAS28(CRP), or the Disease
Activity Score, considers 28 tender and swollen joint counts,
general health, plus levels of an inflammatory biomarker, being
CRP. DAS28(CRP) is used to give an overall picture of the
disease state, resulting in a score on a scale from 0 to 10
indicating current RA disease activity, whereby remission is less
than or equal to 2.6, low disease activity is less than or
equal to 3.2, moderate disease activity is less than or equal
to 5.1, and high disease activity is greater than 5.1.
Conference call and webcast presentation
Galapagos will conduct a
conference call open to the public tomorrow, 28 April 2015, at
16:00 CET/10 AM EDT/8 AM PDT, which will also be webcast. To
participate in the conference call, please call one of the
following numbers ten minutes prior to commencement:
|
Confirmation
Code: |
6206795 |
|
|
|
|
|
|
|
London, United Kingdom: |
+44 20 3478 5300 |
Toll free - United Kingdom: |
0800 279 4841 |
New York, NY, USA: |
+1 718 354 1357 |
Toll free - USA: |
1 877 280 1254 |
Amsterdam, Netherlands: |
+31 20 713 2790 |
Toll free - Netherlands: |
0800 020 2576 |
Brussels, Belgium: |
+32 2 620 0138 |
Toll free - Belgium: |
0800 58032 |
Paris, France: |
+33 1 76 77 22 29 |
Toll free - France: |
0805 631 580 |
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
Galapagos
Galapagos (Euronext: GLPG; OTC: GLPYY) is a clinical-stage
biotechnology company specialized in the discovery and development
of small molecule medicines with novel modes of action, with a
pipeline comprising three Phase 2 programs, two Phase 1 trials,
five pre-clinical studies, and 25 discovery small-molecule and
antibody programs in cystic fibrosis, inflammation, and other
indications. In the field of inflammation, AbbVie and
Galapagos signed a collaboration agreement for the development and
commercialization of filgotinib. Filgotinib is an
orally-available, selective inhibitor of JAK1 for the treatment of
rheumatoid arthritis and potentially other inflammatory diseases,
currently in Phase 2B studies in RA and in Phase 2 in Crohn's
disease. Galapagos reported good activity and a favorable
safety profile at 12 weeks in both the DARWIN 1 and 2 trials in
RA. AbbVie and Galapagos also signed a collaboration
agreement in cystic fibrosis to develop and commercialize molecules
that address mutations in the CFTR gene. Potentiator GLPG1837
is currently in a Phase 1 trial, and corrector GLPG2222 is at the
pre-clinical candidate stage. GLPG1205, a first-in-class
inhibitor of GPR84 and fully-owned by Galapagos, is currently being
tested in a Phase 2 proof-of-concept trial in ulcerative colitis
patients. GLPG1690, a fully proprietary, first-in-class
inhibitor of autotaxin, has shown favorable safety in a Phase 1
trial and is expected to enter Phase 2 in idiopathic pulmonary
fibrosis. 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. Further information at:
www.glpg.com
CONTACT
Galapagos NV
Elizabeth Goodwin, Head of Corporate Communications &
IR
Tel: +31 6 2291 6240
ir@glpg.com
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statements
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statements, including, without limitation, statements concerning
anticipated progress, objectives and expectations regarding the
commercial potential of our product candidates, intended product
development, clinical activity timing, and other objectives and
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These statements are often, but are not always, made through the
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may result in differences are the inherent uncertainties associated
with competitive developments, clinical trial and product
development activities, regulatory approval requirements and
estimating the commercial potential of our product candidates.
Given these uncertainties, the reader is advised not to place any
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forward-looking statements speak only as of the date of publication
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obligation to update any such forward-looking statements in this
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Source: Galapagos NV via Globenewswire
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