Successful completion of End-of-Phase 2 FDA and EMA consultations in rheumatoid arthritis (RA)
May 24 2016 - 4:09PM
- FINCH Phase 3 studies to start in Q3'16
- Three registration studies addressing a broad population of
RA patients
- 100 mg and 200 mg once daily dosing in males and females
world-wide
Galapagos NV (Euronext:GLPG) (NASDAQ:GLPG)
reports the successful completion of the discussions with
the regulatory authorities in the US and Europe and discloses the
doses for the FINCH global Phase 3 program with filgotinib in RA.
The FINCH program will investigate efficacy and safety of 100 mg
and 200 mg filgotinib once-daily, globally addressing a broad RA
patient population, with dosing expected to begin in Q3'16. The
FINCH Phase 3 program will also contain a dedicated male patient
testicular safety study.
"We are pleased with the outcome of the
End-of-Phase 2 discussions with FDA and EMA, as the FINCH program,
led by our collaboration partner Gilead, will enable a
comprehensive Phase 3 evaluation of simultaneously 100 mg and
200 mg filgotinib in both males and females in major RA
patient populations world-wide," said Piet Wigerinck, Chief
Scientific Officer at Galapagos. "Gilead and Galapagos have worked
diligently to complete the transition, such that Gilead is now
poised to initiate multiple studies with filgotinib in inflammatory
diseases."
Galapagos and Gilead entered into a global
collaboration for the development and commercialization of
filgotinib for inflammatory indications. In addition to the FINCH
program in RA, Gilead expects to initiate a Phase 3 study with
filgotinib in Crohn's disease and a Phase 2/3 study in ulcerative
colitis in Q3 '16. Interactions with the regulatory authorities in
these indications are still pending and will be reported on
later.
For more information about filgotinib:
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 maturing 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 440 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 +1 781 460 1784 |
Director
Communications +31 6 53 591 999 communications@glpg.com |
Paul van der Horst Director IR & Business Development +31 6 53
725 199 |
|
ir@glpg.com |
|
Forward-Looking Statements This release may contain
forward-looking statements, including statements regarding any
guidance given by Galapagos' management, the anticipated timing of
clinical studies with filgotinib, the progression and results of
such studies and ongoing interactions with regulatory authorities.
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.
Succesful completion Ph2 consultations in RA
http://hugin.info/133350/R/2015190/747138.pdf
HUG#2015190
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