Consistent safety findings and durable activity with filgotinib treatment of rheumatoid arthritis patients up to week 84 in DARWIN 3 study
(Thomson Reuters ONE) -
Galapagos presents data from DARWIN 3, other filgotinib studies and Galapagos'
GLPG1972 at American College of Rheumatology Meeting 2017
Mechelen, Belgium; 5 November 2017; 3 PM CET - Galapagos NV (Euronext & NASDAQ:
GLPG) announced additional long-term follow-up data for the investigational
agent filgotinib in patients with moderate to severely active rheumatoid
arthritis (RA) from the DARWIN 3 study. In this 84-week analysis of 560 patients
representing 1,708 patient years of exposure, adverse events and treatment
emergent lab abnormalities were consistent with prior safety results and
filgotinib was shown to have durable activity; data are summarized in the
abstract. These data and other filgotinib studies, as well as the Phase 1 First-
in-Human results with Galapagos' investigational agent GLPG1972 in
osteoarthritis, will be presented during the American College of Rheumatology
Annual Meeting 2017 in San Diego, CA.
Following is an overview of all presentations on filgotinib at the ACR Annual
Meeting 2017:
Long Term Safety of Filgotinib in the Treatment of Rheumatoid Arthritis: Week
84 Data from a Phase 2b Open-Label Extension Study, Mark C. Genovese, et al,
#1909, Monday, Nov. 6, 2017, Session "Rheumatoid Arthritis - Small Molecules,
Biologics and Gene Therapy II: Trials Therapy" 4:30 - 6:00pm PT
The JAK1 Selective Inhibitor Filgotinib Regulates Both Enthesis and Colon
Inflammation in a Mouse Model of Psoriatic Arthritis, Catherine Robin-
Jaegerschmidt et al, #497
Correlation of Multi-Biomarker Disease Activity Score with Clinical Disease
Activity Measures for the JAK1-Selective Inhibitor Filgotinib As Monotherapy and
in Combination with Methotrexate in Rheumatoid Arthritis Patients, Mark C.
Genovese, et al, #1458
No Effect of Baseline Serum CRP Levels on Clinical Efficacy Parameters in
Rheumatoid Arthritis Patients Treated with Filgotinib: Post Hoc Analysis from
Two Phase 2B Studies, Arthur Cavanaugh et al, #537
Effect of Baseline MTX Dose on Clinical Efficacy and Safety in Rheumatoid
Arthritis Patients Treated with Filgotinib: Post-Hoc Analysis from a Phase 2B
Study, Rene Westhovens et al, #534
Filgotinib, a Selective Janus Kinase 1 Inhibitor, Has No Effect on QT Interval
in Healthy Subjects, Kacey Anderson et al, #531
Association between Clinical Response and Normalization of Patient-Reported
Outcome Measures in Rheumatoid Arthritis: Post-Hoc Analysis from Two Phase 2b
Filgotinib Studies, Mark C. Genovese et al, #510
Monotherapy with Filgotinib, a JAK1-Selective Inhibitor, Reduces Disease-Related
Biomarkers in Rheumatoid Arthritis Patients, Peter Taylor et al, #504
Lack of Drug-Drug Interaction between Filgotinib, a JAK-1 Selective Inhibitor,
and a Representative Hormonal Contraceptive Medication, Levonorgestrel/Ethinyl
Estradiol, Rebecca Begley et al, #1459
Ex Vivo Comparison of Baricitinib, Upadacitinib, Filgotinib, and Tofacitinib for
Cytokine Signaling in Human Leukocyte Subpopulations, Iain B. McInnes et al,
#2870
Filgotinib is an investigational therapy and its safety and efficacy have not
been established.
GLPG1972 in osteoarthritis
Favorable Human Safety, Pharmacokinetics and Pharmacodynamics of the ADAMTS-5
Inhibitor GLPG1972, a Potential New Treatment in Osteoarthritis, Ellen van der
Aar et al, poster #1189 to be presented on Monday 6 November 2017.
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. Galapagos' pipeline comprises Phase 3 through to
discovery programs in cystic fibrosis, inflammation, fibrosis, osteoarthritis
and other indications. Our target discovery platform has delivered three novel
mechanisms showing promising patient results in, respectively, inflammatory
diseases, idiopathic fibrosis and atopic dermatitis. Galapagos is 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 578 employees, operating from its Mechelen, Belgium headquarters
and facilities in The Netherlands, France, and Croatia. More information at
www.glpg.com.
Contact
Investors:
Elizabeth Goodwin
VP IR & Corporate Communications
+1 781 460 1784
Paul van der Horst
Director IR & Business Development
+31 71 750 6707
ir(at)glpg.com
Media:
Evelyn Fox
Director Communications
+31 6 53 591 999
communications(at)glpg.com
Galapagos forward-looking statements
This release may contain forward-looking statements pertaining to Galapagos,
including, among other things, statements regarding the mechanism of action and
safety and efficacy profile of filgotinib and GLPG1972, or regarding the timing,
progress and/or results of clinical studies with, and plans related to,
filgotinib and GLPG1972, including providing data readouts and updates.
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 that Galapagos' expectations regarding its filgotinib and GLPG1972
development programs 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 program may not support registration or further
development of filgotinib or GLPG1972 due to safety, efficacy or other reasons),
Galapagos' reliance on collaborations with third parties (including its
collaboration partner for filgotinib, Gilead and its collaboration partner for
GLPG1972, Servier), and estimating the commercial potential of filgotinib and
GLPG1972. 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' most recent annual report on form
20-F filed with the SEC and other 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.
GLPG at ACR 2017:
http://hugin.info/133350/R/2147228/823464.pdf
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Galapagos NV via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 05.11.2017 - 15:00 Uhr
Sprache: Deutsch
News-ID 566651
Anzahl Zeichen: 9019
contact information:
Town:
Mechelen
Kategorie:
Business News
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