Galapagos NV (Euronext & NASDAQ: GLPG) announced
today that it will present the full results from DARWIN 1 & 2
studies in rheumatoid arthritis, as well as other findings from
research with filgotinib at the American College of Rheumatology
(ACR) Annual Meeting in San Francisco, CA, from 8-10 November,
2015. Below follows an overview of all oral and poster
presentations; all dates and times are in US format and Pacific
time zone. Posters and slides will be posted to glpg.com on
the day following the presentation session.
Oral Presentation, abstract #1048 Session:
Rheumatoid Arthritis-Small Molecules, Biologics and Gene Therapy
II: Small Molecular Targeted Therapies, Sunday, November 8, 2015;
4:30 PM - 6:00 PM "Filgotinib (GLPG0634), an Oral JAK1 Selective
Inhibitor Is Effective in Combination with Methotrexate in Patients
with Active Rheumatoid Arthritis: Results from a Phase 2B Dose
Ranging Study," Dr Rene Westhovens presenting Over 12 weeks,
filgotinib in combination with MTX demonstrated consistent efficacy
on signs and symptoms of active RA with a rapid onset of
action. The safety profile was favorable and consistent with
previous studies conducted in RA with filgotinib. Oral
Presentation, abstract #1049 Session: Rheumatoid Arthritis-Small
Molecules, Biologics and Gene Therapy II: Small Molecular Targeted
Therapies, Sunday, November 8, 2015; 4:30 PM - 6:00 PM
"Filgotinib (GLPG0634), an Oral JAK1 Selective Inhibitor Is
Effective As Monotherapy in Patients with Active Rheumatoid
Arthritis: Results from a Phase 2B Dose Ranging Study," Dr
Arthur Kavanaugh presenting Over 12 weeks, filgotinib as
monotherapy demonstrated clear efficacy in treating the signs and
symptoms of active RA with a rapid onset of action. Overall
safety profile was favorable and consistent with previous studies
conducted in RA with filgotinib.
Poster presentation, abstract #1663 Session:
Rheumatoid Arthritis - Small Molecules, Biologics and Gene Therapy
Poster II, Monday, November 9, 2015; 9:00 AM - 11:00 AM
"Influence of Age and Renal Impairment on
Pharmacokinetics of Filgotinib (GLPG0634), a Selective JAK1
Inhibitor" Higher age and mild to moderate impairment
of renal function has a limited impact on the PK of
filgotinib. In severe renal impairment, the exposure to
filgotinib's active metabolite is elevated, consistent with its
renal elimination pathway. This was not associated with
safety signals in these Phase 1 studies.
Poster presentation, abstract #1681 Session:
Rheumatoid Arthritis - Small Molecules, Biologics and Gene Therapy
Poster II, Monday, November 9, 2015; 9:00 AM - 11:00 AM
"4-Week Treatment of Rheumatoid Arthritis Patients with the
JAK1-Selective Inhibitor Filgotinib (GLPG0634) Changes Lipid
Profile with a Preferential Increase in HDL" In RA
patients treated for four weeks with filgotinib, the lipid profile
changed, with a preferential increase in HDL, leading to an
improvement in atherogenic index observed at 150 and 300 mg
once-daily doses.
Poster presentation, abstract #1680 Session:
Rheumatoid Arthritis - Small Molecules, Biologics and Gene Therapy
Poster II, Monday, November 9, 2015; 9:00 AM - 11:00 AM
"Selective JAK1 Inhibition with Filgotinib (GLPG0634)
Decreases Plasma Markers of Inflammation and Joint Damage in
Patients with Rheumatoid Arthritis" Treatment with
filgotinib for four weeks in RA patients led to reductions in
relevant inflammation biomarkers, indicating that JAK1 inhibition
is sufficient to address inflammation in RA patients.
Poster presentation, abstract #2763 Session:
Rheumatoid Arthritis - Small Molecules, Biologics and Gene Therapy
Poster III, Tuesday, November 10, 2015; 9:00 AM - 11:00 AM
"Filgotinib (GLPG0634), a Selective JAK1 Inhibitor,
Shows Similar Pharmacokinetics and Pharmacodynamics
Profiles in Japanese and Caucasian Healthy Volunteers"
Filgotinib showed comparable PK, PD and safety profiles in Japanese
and Caucasian healthy volunteers. The similarity in the PK
and PD response suggests that there are no relevant differences
among the groups in drug metabolism or selective inhibition of
JAK1. These data support that filgotinib may be administered
at similar doses in Japanese and Caucasian RA patients.
Poster presentation, abstract #2781 Session:
Rheumatoid Arthritis - Small Molecules, Biologics and Gene Therapy
Poster III, Tuesday, November 10, 2015; 9:00 AM - 11:00 AM
"Absence of Effects of Filgotinib on Erythrocytes, CD8+ and
NK Cells in Rheumatoid Arthritis Patients Brings Further Evidence
for the JAK1 Selectivity of Filgotinib" In RA patients
treated for 4 weeks with filgotinib, the absence of effects on
numerous immune system factors and the improvement seen in
hemoglobin demonstrated the high degree of selectivity for JAK1 of
filgotinib in RA patients.
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, 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. Filgotinib is an
orally-available, selective inhibitor of JAK1 for the treatment of
rheumatoid arthritis and potentially other inflammatory diseases.
Galapagos has reported good activity and a favorable safety profile
in both the DARWIN 1 and 2 trials in RA. Galapagos is
preparing to enter Phase 3 studies in RA and to report Phase 2
topline results with filgotinib in Phase 2 in Crohn's disease.
In the field of cystic fibrosis, AbbVie and Galapagos
collaborate to develop and commercialize molecules that address
mutations in the CFTR gene. Potentiator GLPG1837 is expected
to enter Phase 2 by end 2015, corrector GLPG2222 is expected to
enter Phase 1 by end 2015, and C2 corrector GLPG2665 is expected to
enter Phase 1 by mid 2016. GLPG1205, a first-in-class inhibitor of
GPR84 and fully-owned by Galapagos, will report topline results in
Q1 2016 from 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. More info at www.glpg.com
CONTACT
Galapagos NV
Investors: Elizabeth Goodwin, VP IR &
Corporate Communications Cell: +1 781 460 1784 ir@glpg.com Media
inquiries: Evelyn Fox, Director Communications Tel: +31 6 53 591
999 communications@glpg.com
Galapagos forward-looking statements This release may
contain forward-looking statements, including statements regarding
the promising nature of the results with filgotinib and the
potential implications of these results for the future risk-benefit
profile of filgotinib. 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 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 in rheumatoid arthritis and Crohn's disease may
not support registration or further development of filgotinib 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)
filing and reports, including in Galapagos' prospectus filed with
the SEC on 14 May 2015 and future filings and reports filed by the
company 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.
HUG#1965207
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