Galapagos' R&D Update 2017: rapidly advancing our product candidates
(Thomson Reuters ONE) -
* Filgotinib
* Darwin 3: improved activity, consistent safety parameters for filgotinib
* Ph2 studies initiated in 6 new indications
* Cystic fibrosis
* Three different triple combos in development
* Successful completion of Ph1 with three individual combo components
* Start of regulatory process next month, patient study with first triple
combo expected to begin in Q4 '17 in Europe
* Topline data for GLPG1690 in IPF in Q3 '17
* Opening of US IND and dosing of first osteoarthritis patient in Phase 1b
trial with GLPG1972
* Growing number of clinical stage proprietary programs in fibrosis,
psoriasis, and other indications
Webcast from NY at 14.00 CET/8AM ET tomorrow
via www.glpg.com, +32 2 404 0659, code 8093710
Mechelen, Belgium; 20 June 2017; 7.30 CET, regulated information - Galapagos NV
(Euronext & NASDAQ: GLPG) announces progress made in its R&D strategy and
portfolio at its Annual R&D Update on 20 June at 8 AM EDT at the Yale Club in
New York City.
"I am emboldened by the execution of our strategy by the Galapagos teams that
has resulted in great opportunities for our company. Galapagos now has a broad
and deep pipeline with multiple product candidates across different indications.
We have five proprietary clinical assets and the cash reserves to take these
product candidates forward on our own into clinical development," said CEO Onno
van de Stolpe.
DARWIN 3 interim readout
Patients who completed DARWIN 1 or 2 and enrolled in DARWIN 3 received
filgotinib 200mg once daily or 100mg twice daily, depending on prior treatment
assignment. A total of 559 patients completed week 60. Based on an observed case
analysis 84%, 65%, 44%, and 51% of patients reached ACR20, ACR50, ACR70 and
DAS28 (CRP) remission at Week 60 respectively. Overall exposure to filgotinib
was 1314 patient-years (PYE). Safety was in line with the core studies. There
were no clinically meaningful changes to male reproductive hormones measured.
The totality of these safety data continues to reflect a favorable profile for
filgotinib in the target population. Filgotinib is currently being investigated
in three Phase 3 programs and six additional Phase 2 proof-of-concept studies:
ankylosing spondylitis, psoriatic arthritis, cutaneous lupus erythematosus,
Sjögren's syndrome, small bowel Crohn's, and fistulizing Crohn's. As filgotinib
is currently in Phase 3 studies, the efficacy and safety of filgotinib have not
yet been established.
Cystic fibrosis triple combinations
Galapagos and AbbVie have developed a large portfolio of potentiators and
correctors that provides the opportunity to develop distinct triple combination
therapies for CF patients. Galapagos reports that Phase 1 results on GLPG2451,
GLPG2222 and GLPG2737 showed favorable findings relating to safety and
tolerability of the individual components that constitute our current most
advanced potential triple combination therapy. These results lead Galapagos to
initiate that triple combination program, including start of the regulatory
review process in Europe next month, which should allow for a patient study with
'2737 in combination with Orkambi[1] and the first patient study with the triple
combination '2451, '2222, and '2737 to start in Q4 2017. In addition, Galapagos
anticipates starting two triple studies in 2018: one with '3067, '2222, and
'2737 and one with '3067, '2222, and '3221.
Idiopathic pulmonary fibrosis: orphan drug status in US and topline data
expected for GLPG1690 from FLORA study
Galapagos received orphan status for GLPG1690 in IPF from the US Food & Drug
Administration (FDA). Galapagos has full commercial rights for '1690 and expects
to announce topline results from an exploratory Phase 2a study with '1690 in IPF
patients in the third quarter of 2017.
Osteoarthritis: GLPG1972 being tested in patients in the US
Galapagos is developing GLPG1972, targeting ADAMTS-5, as a potential disease-
modifying therapy for osteoarthritis. Galapagos has full commercial rights in
the US. Our collaboration partner Servier will be making its opt-in decision for
further development and ex-US commercial rights later this year. Galapagos
opened an Investigational New Drug (IND) dossier with the FDA for '1972 and
achieved first dosing in a Phase 1b patient trial in the US. This exploratory
dose escalation study will investigate the safety and tolerability,
pharmacokinetics and pharmacodynamics of '1972 in 30 patients with hip and/or
knee osteoarthritis after 4 weeks of oral administration. Completion of patient
recruitment is expected by the end of 2017.
Additional pipeline progress
Galapagos expects to report topline results with MOR106, a human monoclonal
antibody targeting IL-17C, in a Phase 1b trial in atopic dermatitis patients
later in 2017. Furthermore, Galapagos expects to initiate a new study with GPR84
inhibitor GLPG1205 in an undisclosed indication later in 2017. Galapagos
nominated GLPG2384 in an undisclosed indication and GLPG3121 in psoriasis,
increasing the number of fully proprietary clinical stage assets to five.
Webcast presentation and conference call
Galapagos will webcast the R&D Update tomorrow (20 June 2017) 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: 8093710
USA: +1 719 325 4746
UK: +44 330 336 9105
Netherlands: +31 20 721 9251
France: +33 1 76 77 22 74
Belgium: +32 2 404 0659
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 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 Phase 3, 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 530 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
This press release contains inside information within the meaning of Regulation
(EU) No 596/2014 of the European Parliament and of the Council of 16 April 2014
on market abuse (market abuse regulation)
Forward-looking statements
This release may contain forward-looking statements, including, among other
things, statements regarding the expectations from management, the anticipated
timing and results of clinical studies and the potential activity of filgotinib
in inflammatory indications, GLPG2222, GLPG2451, GLPG2737 and of potential
triple combinations 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 GLPG1690 for idiopathic pulmonary
fibrosis, MOR106 for atopic dermatitis, GLPG3121 in psoriasis, GLPG1205, and
GLPG2384. 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.
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[1] Orkambi® is a registered drug of Vertex Pharmaceuticals
R&D Update 2017:
http://hugin.info/133350/R/2114323/804429.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: 20.06.2017 - 07:30 Uhr
Sprache: Deutsch
News-ID 548712
Anzahl Zeichen: 12338
contact information:
Town:
Mechelen
Kategorie:
Business News
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