FINCH filgotinib Phase 3 program initiated in rheumatoid arthritis
August 22 2016 - 4:09PM
- 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, Aug. 22, 2016 (GLOBE NEWSWIRE)
-- 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 Paul van
der Horst Director IR & Business Development +31 6 53 725
199 |
+31 6 53 591 999
communications@glpg.com |
ir@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.
[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
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