Galapagos to advance filgotinib to Phase 3 in rheumatoid arthritis
September 25 2015 - 10:48AM
- Galapagos regains all unencumbered rights to
filgotinib
- Filgotinib is the most selective JAK1 inhibitor
- Best-in-class efficacy and safety in RA in 24-week Phase 2B
studies in 877 patients
- Phase 3 start in RA expected in early 2016
Galapagos to hold a conference call open to the public
today at 17.15 CET/11:15 AM EDT CODE:
830162
UK: |
+44 330 336 6025 |
USA: |
+1 719 325 2556 |
Belgium: |
+32 2400 6966 |
NL: |
+31 207 940454 |
France: |
+33 176 7722 61 |
Mechelen, Belgium; 25 September 2015:
Galapagos NV (Euronext & NASDAQ: GLPG) announced today that the
Company will be moving filgotinib, its highly selective JAK1
inhibitor, into Phase 3 in rheumatoid arthritis by early
2016. Filgotinib has shown best-in-class efficacy and safety
in the DARWIN Phase 2B studies in rheumatoid arthritis and is now
fully owned by Galapagos.
Galapagos has demonstrated that high
selectivity for JAK1 results in excellent efficacy and safety in
rheumatoid arthritis patients. Based on our own human whole
blood assays comparing ABT-494 to filgotinib, filgotinib is
three-fold more JAK1 selective than ABT-494. Galapagos
reported best-in-class efficacy and safety in 24-week Phase 2B
studies in 877 patients with filgotinib. Furthermore,
Galapagos has more than 700 patient-years of treatment
experience with filgotinib in RA patients, of which more than 500
years at the highest 200 mg dose, all with a clean safety
profile consistent with JAK1 inhitbition: filgotinib showed a clear
dose dependent increase in hemoglobin concentration without any
impact on NK cells and lymphocyte counts.
"We see a rapid path forward in development for
filgotinib, which we will be taking into Phase 3. Galapagos
is currently in advanced discussions with a substantial number of
large pharma companies to partner filgotinib. We
anticipate starting Phase 3 in rheumatoid arthritis with filgotinib
early in 2016 and we are expecting data from our Phase 2B FITZROY
study with filgotinib in Crohn's disease by yearend,"said
Onno van de Stolpe, CEO of Galapagos.
On efficacy, Galapagos consistently has reported
ACR scores using the most conservative NRI approach. The
table below shows the ACR scores for the DARWIN 1 study at 24-weeks
on the LOCF basis, for comparison purposes :
DARWIN1 (MTX-IR) |
ACR20 |
ACR50 |
ACR70 |
50mg, once-daily |
61* |
35** |
22* |
100mg, once-daily |
74*** |
54*** |
38*** |
200mg, once-daily |
78*** |
55*** |
31** |
25mg, twice-daily |
62* |
38** |
22* |
50mg, twice-daily |
66* |
38** |
25* |
100mg, twice-daily |
87*** |
62*** |
43*** |
placebo |
45 |
16 |
9 |
* p< 0.05 vs. placebo; ** p<0.01 vs.
placebo; *** p<0.001 vs. placebo; ACR scores based on LOCF
analysis
AbbVie notified Galapagos today of termination of the
agreement on filgotinib.
Conference call and webcast presentation
Galapagos will conduct a conference call open to
the public today (25 September 2015) at 17:15 CET/11:15 AM
EDT. To participate in the conference call, please call one
of the following numbers ten minutes prior to commencement:
CODE: 830162
UK: |
+44 330 336 6025 |
USA: |
+1 719 325 2556 |
Belgium: |
+32 2400 6966 |
NL: |
+31 207 940454 |
France: |
+33 176 7722 61 |
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, with a pipeline comprising three Phase 2 programs, two
Phase 1 trials, five pre-clinical studies, and 20 discovery
small-molecule and antibody programs in cystic fibrosis,
inflammation, and other indications. Filgotinib is an
orally-available, selective inhibitor of JAK1 for the treatment of
rheumatoid arthritis and potentially other inflammatory diseases,
currently in Phase 2B studies in RA and in Phase 2 in Crohn's
disease. Galapagos reported good activity and a favorable safety
profile in both the DARWIN 1 and 2 trials in RA. In the field
of cystic fibrosis, AbbVie and Galapagos signed a collaboration
agreement to develop and commercialize molecules that address
mutations in the CFTR gene. Potentiator GLPG1837 is currently
in a Phase 1 trial, and corrector GLPG2222 is at the pre-clinical
candidate stage. GLPG1205, a first-in-class inhibitor of
GPR84 and fully-owned by Galapagos, is currently being tested in a
Phase 2 proof-of-concept trial in ulcerative colitis
patients. GLPG1690, a fully proprietary, first-in-class
inhibitor of autotaxin, has shown favorable safety in a Phase 1
trial and is expected to enter Phase 2 in idiopathic pulmonary
fibrosis. The Galapagos Group, including fee-for-service
subsidiary Fidelta, has approximately 400 employees, operating from
its Mechelen, Belgium headquarters and facilities in The
Netherlands, France, and Croatia. More info at
www.glpg.com
CONTACT
Galapagos NV Elizabeth Goodwin, Head of
Corporate Communications & IR Tel: +31 6 2291 6240
ir@glpg.com
Galapagos forward-looking statements
This release may contain forward-looking statements, including
without limitation statements regarding the possibility and timing
of the initiation of Phase 3 activities in rheumatoid arthritis
with filgotinib, the possibility of partnering filgotinib with a
third partyand filgotinib's safety and/or efficacy profile.
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 Galapagos' ongoing DARWIN and FITZROY
programs with filgotinib may not support registration or further
development of filgotinib due to safety, efficacy or other
reasons), Galapagos' reliance on collaborations with third parties,
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 filing and reports, including in Galapagos'
prospectus filed with the SEC on May 14, 2015 and future filings
and reports by Galapagos. 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.
HUG#1954667
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