Bli medlem
Bli medlem

Du är här


Galapagos NV: Galapagos' JAK1 inhibitor filgotinib (GLPG0634) meets primary and other key efficacy endpoints after 12 weeks of treatment in DARWIN 1 Phase 2B s

* 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
+32 2 789 2126, access code5188327
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
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 50 mg 100 mg 200 mg 25 mg 50 mg 100 mg |
| |
| n=86 n=82 n=85 n=86 n=86 n=85 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

§ 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 presentationGalapagos 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 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
offilgotinib. 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. PotentiatorGLPG1837is 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 idiopa...

Författare Hugin

Tala om vad ni tycker

Tala om vad ni tycker

Ni är just nu inne på en betaversion av nya aktiespararna. Lämna gärna feedback på vad ni tycker i formuläret nedan.