Galapagos' R&D Update 2016
(Thomson Reuters ONE) -
* 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; 15 June 2016: 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 Director Communications
Communications +31 6 53 591 999
+1 781 460 1784 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, among other
things, statements regarding theexpectations 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 thatGalapagos' 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
This announcement is distributed by GlobeNewswire on behalf of
GlobeNewswire clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Galapagos NV via GlobeNewswire
[HUG#2020745]
Unternehmensinformation / Kurzprofil:
Datum: 15.06.2016 - 07:30 Uhr
Sprache: Deutsch
News-ID 477734
Anzahl Zeichen: 10041
contact information:
Town:
Mechelen
Kategorie:
Business News
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