FINCH filgotinib Phase 3 program initiated in rheumatoid arthritis
(Thomson Reuters ONE) -
* Three studies addressing a broad population of patients with active
rheumatoid arthritis
* Filgotinib 100 mg and 200 mg, once daily dosing in males and females
worldwide in combination- and as monotherapy
Mechelen, Belgium; 22 August 2016 - Galapagos NV (Euronext & NASDAQ: GLPG)
reports the initiation of the FINCH global Phase 3 program investigating the
efficacy and safety of 100 mg and 200 mg filgotinib once daily, in rheumatoid
arthritis (RA) patient populations, ranging from early stage to biologic-
experienced patients.
The FINCH program includes three studies with filgotinib. FINCH 1 is a 52-week,
randomized, placebo- and adalimumab-controlled study in combination with
methotrexate (MTX) in an expected 1,650 patients who have had inadequate
response to MTX. The primary endpoint is ACR20[1] at week 12. The study will
also include radiographic assessment at weeks 24 and 52.
FINCH 2 is a 24-week, randomized, placebo-controlled study in an expected 423
patients who are on conventional disease-modifying anti-rheumatic drugs
(cDMARD), and have had an inadequate response to biological treatment. The
primary endpoint is ACR20 at week 12.
FINCH 3 is a 52-week, randomized study in an expected 1,200 MTX-naïve patients
to study filgotinib in combination with MTX, as well as monotherapy. The primary
endpoint is ACR20 at week 24. Radiographic progression will also be assessed.
"The FINCH program, led by our collaboration partner Gilead Sciences, Inc., is
designed to enable a comprehensive evaluation of 100 mg and 200 mg filgotinib
once daily in early stage to biologic-resistant RA patient populations," said
Piet Wigerinck, Chief Scientific Officer at Galapagos. "Preparations are well
underway to also initiate studies with filgotinib in Crohn's disease and
ulcerative colitis in Q4 of this year."
The FINCH program in RA will be conducted in the United States and Europe to
start, with other regions to follow. For more information, visit
www.clinicaltrials.gov.
Galapagos and Gilead have entered into a global collaboration for the
development and commercialization of filgotinib for inflammatory indications.
Filgotinib is an investigational agent and its safety and efficacy have not been
established. For more information, check www.glpg.com/filgotinib.
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. Our pipeline comprises a pipeline of Phase 2, Phase 1,
pre-clinical, and discovery programs in cystic fibrosis, inflammation, fibrosis,
osteoarthritis and other indications. We have discovered and developed
filgotinib; in collaboration with Gilead we aim to bring this JAK1-selective
inhibitor for inflammatory indications to patients all over the world. 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 460 employees, operating from its
Mechelen, Belgium headquarters and facilities in The Netherlands, France, and
Croatia. More information at www.glpg.com.
Contacts
Investors: Media:
Elizabeth Goodwin Evelyn Fox
VP IR & Corporate Communications Director Communications
+1 781 460 1784 +31 6 53 591 999
communications(at)glpg.com
Paul van der Horst
Director IR & Business Development
+31 6 53 725 199
ir(at)glpg.com
Forward-Looking Statements
This release may contain forward-looking statements, including statements
regarding the anticipated timing of clinical studies with 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 the ongoing and planned clinical research programs in rheumatoid
arthritis, Crohn's disease and/or ulcerative colitis may not support
registration or further development of filgotinib due to safety, efficacy or
other reasons), Galapagos' reliance on collaborations with third parties
(including its collaboration partner for filgotinib, Gilead), 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) filings and reports,
including in Galapagos' most recent annual report on form 20-F filed with the
SEC and subsequent 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.
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[1] American College of Rheumatology 20% (ACR20) response rate signifies a 20%
or greater improvement in the number of swollen and tender joints as well as a
20% or greater improvement in three out of five other disease-activity measures.
ACR 50 and ACR70 reflect the same, respectively for 50% and 70% response rates.
FINCH filgotinib Phase 3 program initiated in RA:
http://hugin.info/133350/R/2036608/758706.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: 22.08.2016 - 22:00 Uhr
Sprache: Deutsch
News-ID 490492
Anzahl Zeichen: 7914
contact information:
Town:
Mechelen
Kategorie:
Business News
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