-
ACR20 scores up to 80% at 12
weeks
-
Statistically significant ACR50
and DAS28(CRP) scores with all doses
-
Patient-reported improvements
observed after one week of treatment
-
Safety profile is consistent
with previous filgotinib RA studies
Webcast presentation
of the results to be held on 15 April 2015, 16.00 CET/10 AM EDT/7
AM PDT, +32 2 789 2126,
access code 5188327,
more call number info further
down
Mechelen,
Belgium; 14 April 2015: Galapagos NV (Euronext: GLPG)
announced today that the selective JAK1 inhibitor
filgotinib showed improvements in signs and symptoms of active
rheumatoid arthritis and met key efficacy endpoints after 12 weeks
of treatment with filgotinib as an add-on to methotrexate, or MTX, in the DARWIN 1
Phase 2B study. The study achieved its primary endpoint with
a statistically significant improvement in ACR20 score versus
placebo after 12 weeks of treatment at a daily dose of 200 mg.
Statistically significant ACR50 scores were achieved with all
dose levels and dose regimens. Statistically significant
improvement in DAS28(CRP) was seen within one week. In this
study, filgotinib was well tolerated. Hemoglobin levels
increased. The total cholesterol over
HDL ratio improved with dose. These
first results in the ongoing 24 week study are consistent with the
efficacy/safety profile of filgotinib observed in the prior 4-week
clinical studies.
DARWIN 1 is an ongoing, 24 week,
double-blind, placebo-controlled evaluation of filgotinib, as once-
and twice-daily administration (QD and BID dosing) at 3 daily dose
levels. Results were reported for 594 patients with moderate to
severe rheumatoid arthritis who showed an inadequate response to
methotrexate and who remained on their background therapy of
methotrexate. These patients received filgotinib or placebo
and 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 1 around the middle of the year.
Summary of the ACR/DAS28(CRP)
scores at 12 weeks treatment:
|
|
Once-daily dosing |
Twice-daily dosing |
|
Placebo
n=86 |
50
mg
n=82 |
100
mg
n=85 |
200
mg
n=86 |
25
mg
n=86 |
50
mg
n=85 |
100
mg
n=84 |
ACR20 responders, NRI, % |
45 |
56 |
62 |
69* |
57 |
59 |
80*** |
ACR50 responders, NRI, % |
15 |
32* |
39** |
43*** |
28* |
34* |
55*** |
ACR70 responders, NRI, % |
8 |
16 |
20 |
24* |
14 |
19 |
31** |
DAS28(CRP), mean change from baseline, LOCF § |
-1.2 |
-1.8* |
-2.2*** |
-2.5*** |
-1.9** |
-2.1*** |
-2.8*** |
* p< 0.05 vs. placebo; **
p<0.01 vs. placebo; *** p<0.001 vs. placebo; ACR scores
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 on a last observation carried forward (LOCF)
basis.
Overall, there were no
statistically relevant differences for the once-daily and
twice-daily dosing regimens. The results suggest a rapid
onset of activity, already after one week of treatment.
Over all dose groups including
placebo, 1.7% of patients stopped treatment during the study for
safety reasons. Because of the low number of discontinuations, the
actual distribution across treatment groups is not disclosed to
prevent individual treatment unblinding while the study is still
ongoing. Serious (1.3% overall) and non-serious
treatment-emergent adverse events were evenly spread over the dose
groups including placebo. The rare frequency adverse events
remain blinded for the treatment group and include 3 cases (0.5% of
patients) of serious infections. Consistent with its
selective JAK1 inhibition, filgotinib treatment led to a
dose-dependent improvement in hemoglobin (up to 0.4 g/dL, or 3.7%
increase from baseline). All lipid fractions including HDL
and LDL increased, with the largest percentage increase in HDL
leading to an improved total cholesterol over HDL ratio
(atherogenic index) at 200 mg/day.
"The last decade saw an important
progress in RA treatment with biologicals," said Prof. René
Westhovens from the University of Leuven, Belgium, and Principal
Investigator for DARWIN 1. "The current data with this oral
drug spell hope for a potential future treatment option that
combines fast onset of action and ease of administration. I
am particularly impressed by the rapid improvement reported by the
patients. Also the increase in hemoglobin is important for my
patients, as this may lessen fatigue and enhance their overall
well-being."
"I am very pleased to see that
filgotinib treatment in DARWIN 1, one of the largest Phase 2
studies in RA to date, shows consistent efficacy with fast onset of
action. Its selective inhibition of JAK1 also leads to a
differentiated safety profile, as measured by an improvement in
hemoglobin and overall lipid profile. Today's results with 12
weeks' treatment with filgotinib met the key efficacy endpoints and
are in line with what Galapagos showed in two previous 4-week
studies in RA patients. Based on these 12-week results in RA,
we believe that filgotinib has a promising future to address a
significant medical need. We look forward to seeing the
DARWIN 2 monotherapy results in just a few weeks," said Dr Piet
Wigerinck, Chief Scientific Officer of Galapagos.
About the DARWIN
1 trial and its measures
The primary endpoint of the DARWIN 1 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
1 study, at week 12, subjects on placebo or lower doses of
filgotinib who have not achieved 20% improvement in swollen joint
count and tender joint count will be re-randomized automatically to
another treatment arm with either a 50 mg (twice daily) or 100mg
(once daily) dose. Subjects in the other groups 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.
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 >5.1.
Conference call and webcast presentation
Galapagos will conduct a
conference call open to the public tomorrow, 15 April 2015, at
16:00 CET/10 AM EDT/7 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: |
5188327 |
|
|
|
|
London, United Kingdom: |
+44 20 3427 1903 |
|
Toll free - United Kingdom: |
0800 279 4977 |
|
New York, United States of America: |
+1646 254 3366 |
|
Toll free - United States of America: |
1877 280 1254 |
|
Amsterdam, Netherlands: |
+31 20 716 8256 |
|
Toll free - Netherlands: |
0800 020 2577 |
|
Brussels, Belgium: |
+32 2 789 2126 |
|
Toll free - Belgium: |
0800 58032 |
|
Paris, France: |
+33 1 76 77 22 24 |
|
Toll free - France: |
0805 631 579 |
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 20 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. 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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estimating the commercial potential of our product candidates.
Given these uncertainties, the reader is advised not to place any
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