- 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 tomorrowvia
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
combinationsGalapagos 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
studyGalapagos 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 progressGalapagos
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
callGalapagos 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 GalapagosGalapagos (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 Communications+1 781 460 1784 |
Director
Communications +31 6 53 591 999 communications@glpg.com |
Paul van der HorstDirector IR & Business Development+31 6 53
725 199 |
|
ir@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 statementsThis 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.
[1] Orkambi® is a registered drug of Vertex Pharmaceuticals
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