Galapagos' R&D Update 2016
June 15 2016 - 1:36AM
- C1 corrector GLPG2222 for cystic fibrosis (CF) and GLPG1972
in osteoarthritis well-tolerated and no emerging safety signals
observed in healthy volunteers
- GLPG1972 strongly reduces OA cartilage breakdown biomarker
within two weeks
- New pre-clinical candidates GLPG2938 for idiopathic
pulmonary fibrosis and GLPG2534 for atopic dermatitis
- Deep pipeline of inflammation, fibrosis, metabolic, and
anti-infective programs based on novel mechanisms of
action
- Building pipeline with the aim to initiate one Phase 3
program every two years and three clinical Proofs-of-Concept per
year
Webcast at 14.00 CET/8 AM ET today on
www.glpg.com , +32 2 404 0662, code 207496
MECHELEN, Belgium, June 15, 2016 (GLOBE NEWSWIRE) --
Galapagos (Euronext & NASDAQ: GLPG) will present its R&D
strategy, focus areas and new data on several programs in its
maturing pipeline in inflammation and fibrosis at the Yale Club in
New York City.
Galapagos reports that GLPG2222, the first early binding (C1)
corrector, passed the safety hurdle in Phase 1 studies in healthy
volunteers. GLPG2222 was tested in single ascending doses up to 800
mg, and in multiple ascending doses up to 600 mg qd for 14 days in
a double-blind, randomized, placebo-controlled study. The
candidate drug was shown to be well-tolerated and no emerging
safety signals observed in the dose range studied. Absorption of
GLPG2222 was rapid and favorable. Pharmacokinetics of GLPG2222
support once-daily dosing regimens to be explored in further
development. Corrector GLPG2222 will be tested next with
potentiator GLPG2451 in healthy volunteers. Corrector GLPG2222 is
one of the potential modulator compounds for the triple combination
therapy that Galapagos and AbbVie are developing, aiming to address
90% of all CF patients.
In osteoarthritis, Galapagos reports that GLPG1972, partnered
with Servier, demonstrated a marked biomarker response indicative
for inhibition of cartilage degradation. GLPG1972 was safe and
well-tolerated in healthy volunteers in a Phase 1 study. The
candidate drug demonstrated favorable pharmacokinetics. The
mechanism of action of GLPG1972 remains undisclosed. Galapagos and
partner Servier are considering next steps for further development
of GLPG1972 in osteoarthritis. Galapagos has the full US commercial
rights in the osteoarthritis collaboration with Servier.
Furthermore, Galapagos announces the nomination of two new
pre-clinical candidates with undisclosed novel mechanisms of
action: GLPG2938 for idiopathic pulmonary fibrosis and GLPG2534 for
atopic dermatitis. Both programs are expected to enter Phase 1 in
2017.
The Company will present the discovery portfolio and its
evolution. Aim is to evolve to a stable portfolio delivering three
clinical Proofs-of-Concept per year and to initiate one Phase 3
program every two years.
Webcast presentation and conference call Galapagos will
webcast the R&D Update today (15 June 2016) at 8.00 Eastern
Time (ET) and 14:00 Central European Time (CET), together with a
conference call. To participate in the latter, please call one of
the following numbers ten minutes prior to commencement:
CODE: 207496
USA: |
+1 212 444 0481 |
UK: |
+44 20 3427 1907 |
Netherlands: |
+31 20 713 2998 |
France: |
+33 1 70 48 01 66 |
Belgium: |
+32 2 404 0662 |
A question and answer session will follow the presentation of
the R&D Update. Go to www.glpg.com to access the live audio
webcast. The archived webcast will also be available for replay
shortly after the close of the call.
About Servier Servier is an international pharmaceutical
company with over 21,000 employees in 148 countries. Corporate
growth is driven by Servier's constant search for innovation in
five areas of excellence: oncology, cardiology, metabolism,
neuropsychiatry and rheumatology. Servier is an independent company
that reinvests all earnings in its development and activities. In
2015, the company recorded a turnover of €3.9 billion. For more
information, visit: www.servier.com.
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 maturing pipeline comprises Phase 2, Phase 1,
pre-clinical and discovery studies 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, among other things,
statements regarding the expectations from management, the
anticipated timing of clinical studies and the potential activity
of GLPG2222, GLPG2451, and of a potential triple combination
including any of these compounds for cystic fibrosis, the
anticipated timing of clinical studies and the potential activity
of GLPG1972 for osteoarthritis, the further development of GLPG2938
for idiopathic pulmonary fibrosis and GLPG2534 for atopic
dermatitis, and management's goals for future initiation of Phase 3
trials and delivery of clinical Proofs-of-Concept. 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 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 programs may not support registration or further
development of its product candidates due to safety, efficacy or
other reasons), Galapagos' reliance on collaborations with third
parties, and estimating the commercial potential of its development
programs. 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.
Galapagos' R&D Update 2016
http://hugin.info/133350/R/2020745/750602.pdf
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