- Positive results with FLAMINGO study
- C1 corrector GLPG2222 as monotherapy in homozygous
Class II F508del CF patients
- Study over-recruited within 5 months in the US and
Europe
- GLPG2222 was well tolerated when dosed once daily for
28 days
- Dose dependent decrease in sweat chloride
observed
- Start of Phase 1 study with backup novel C1 corrector
GLPG2851, triggering $10 M milestone payment to Galapagos from
AbbVie
- First dosing of PELICAN Phase 2 study of C2 corrector
GLPG2737 in combination with Orkambi®[1] in homozygous Class II
F508del CF patients
- Dosing of first patient with first investigational
triple combination expected in Q1 2018, interim readout
mid-2018
- First dosing in Phase 1 study with second
investigational triple combination therapy in healthy volunteers
with combination of GLPG3067+GLPG2222+GLPG2737
Mechelen, Belgium; 2 January 2017, 22.01 CET
- Galapagos NV (Euronext & NASDAQ: GLPG) provided an update on
several aspects of its cystic fibrosis (CF) programs: Galapagos
started three new clinical studies, concluded the FLAMINGO study in
CF patients, and expects to report patient data with a first
proprietary investigational triple combination therapy in mid-2018.
Galapagos, together with collaboration partner AbbVie, stays on
track to deliver a competitive triple combination therapy to target
90% of the CF patient population that have the Class II
mutation.
Positive topline results from FLAMINGO Phase
2 study The FLAMINGO study included 59 cystic fibrosis (CF)
patients with two copies of the Class II F508del mutation and
who had not received prior treatment with Orkambi or
tezacaftor-ivacaftor®[2] for four weeks prior to dosing of
GLPG2222. The FLAMINGO study was over-recruited within five months.
This is the first Galapagos CF patient study conducted in the
United States as well as in Europe.
Primary objectives of this randomized,
double-blinded, placebo controlled study were to evaluate the
safety and tolerability of novel C1 corrector GLPG2222. Once daily
doses of GLPG2222 or placebo were administered for a total of four
weeks on treatment. All patients completed the full treatment
course.
Overall, GLPG2222 was well tolerated, with
observed treatment emergent adverse events being predominantly mild
or moderate and typical for a CF patient population. A total of
four Serious Adverse Events (SAEs) were reported in three patients.
Of these, two patients were on placebo, each experiencing pulmonary
exacerbations due to infection. One patient was on Dose B of
GLPG2222 and experienced two pulmonary exacerbations, both with
onset during the follow up period; this patient had a significant
sweat chloride decrease up to Day 29. There were no
discontinuations due to adverse events.
The study doses achieved the targeted GLPG2222
exposure levels. These will provide support to dose modelling and
dose selection for the first investigational triple combination.
Consistent with the ALBATROSS patient study, exposures achieved in
patients were in line with those observed in healthy
volunteers.
A statistically significant dose-dependent
decrease in sweat chloride concentration was observed with a
maximum decrease of 18.3 mmol/L in the Dose C cohort. Mean percent
predicted FEV1 (ppFEV1) levels overall were 63.4% at screening
(prior to treatment with GLPG2222). Consistent with expectation and
similar prior VRTX studies, there was no significant impact on
ppFEV1 levels.
|
Placebo (n=11) |
Dose A (n=10) |
Dose B (n=10) |
Dose C (n=14) |
Dose D (n=14) |
Sweat chloride, mean change Day 15 vs baseline, in
mmol/L |
-5.0 (2.93^) |
-9.6 (3.24) |
-7.7 (3.46) |
-16.2 (2.62)* |
-12.5 (2.62) |
Sweat chloride, mean change Day 29 vs baseline, in
mmol/L |
-2.5 (2.79) |
-5.8 (3.08) |
-6.6 (3.29) |
-18.3 (2.49)* |
-8.8 (2.49) |
* = p<0.05 (pairwise comparison with
Placebo)^= LS-means (SE) from an ANCOVA model with treatment as
factor and baseline as covariate with LOCF (Last Observation
Carried Forward) method
"We are pleased to have recruited this
relatively large study so rapidly during a time in which Vertex was
recruiting for its Phase 3 with tezacaftor and ivacaftor. The
FLAMINGO results, coming on the back of the positive ALBATROSS
patient study findings, further support that GLPG2222 was well
tolerated in CF patients. In addition, the exposures achieved,
coupled with the activity observed on sweat chloride, support our
dose selection plans for the triple combination therapy," said Dr.
Piet Wigerinck, CSO of Galapagos. "C1 corrector GLPG2222 is the
most validated component for all our investigational triple
combination therapies planned."
Start of Phase 1 study with GLPG2851, $10
million milestone paymentA Phase 1 study with backup novel C1
corrector GLPG2851 for cystic fibrosis (CF) has started, triggering
a $10 million milestone payment from its collaboration partner
AbbVie for this achievement.
The aim of the Phase 1 study is to evaluate the
safety, tolerability and pharmacokinetics of GLPG2851 in healthy
volunteers. The randomized, double-blind, placebo controlled,
single center study is being conducted in Belgium. Topline results
from this Phase 1 study are expected to be disclosed at a future
medical conference.
In order to bring a more effective therapy to
the majority of CF patients, Galapagos and AbbVie have a large
portfolio of candidates addressing three complementary components
for a potential combination therapy. GLPG2851 is the second C1
corrector, chemically distinct from the same series as the first C1
corrector. It will be a back-up corrector for the triple combo's
expected to be tested in patients in the future. Both C1 and C2
series of correctors have different modes of action.
First dosing of PELICAN Phase 2 study with
GLPG2737 in combination with OrkambiFirst dosing of a CF
patient has taken place in the PELICAN study, which is being run in
10 sites in Germany. The aim of the double-blind,
placebo-controlled Phase 2 study is to evaluate the safety and
tolerability of novel C2 corrector GLPG2737 in adult CF patients
who are homozygous for the Class II F508del mutation.
Patients will remain on their stable dose of Orkambi and will
receive treatment with GLPG2737 over a period of 4 weeks, with up
to 3 weeks' follow up. Secondary endpoints include measurements of
sweat chloride, ppFEV%, and CFQ-R. Topline results are expected in
H1 2018.
Expected first dosing of CF patient with
investigational triple combination therapyGalapagos announces
that discussions with the UK MHRA are ongoing and Galapagos expects
to dose the first patient with an investigational triple
combination therapy - comprising potentiator GLPG2451, C1 corrector
GLPG2222, and C2 corrector GLPG2737 - in Q1 2018. An interim
readout from this first triple combination patient study is
expected in the summer of 2018.
First dosing in Phase 1 study with second
triple combinationThe first healthy volunteer was dosed with
novel investigational triple combination therapy comprising
potentiator GLPG3067, C1 corrector GLPG2222, and C2 corrector
GLPG2737 in a Phase 1 study in Belgium. The aim of the Phase 1,
randomized, double-blinded, placebo-controlled study is to evaluate
the safety, tolerability and pharmacokinetics of multiple ascending
doses of this second investigational triple combination therapy in
up to 16 healthy volunteers. Topline results from this Phase 1
study are expected to be presented at a future medical
conference.
GLPG2222, GLPG2451, GLPG2737, GLPG2851, GLPG3067
are investigational therapies; their safety and efficacy have not
been established.
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. Galapagos' pipeline comprises Phase 3 through to discovery
programs in cystic fibrosis, inflammation, fibrosis, osteoarthritis
and other indications. Our target discovery platform has delivered
three novel mechanisms showing promising patient results in,
respectively, inflammatory diseases, idiopathic fibrosis and atopic
dermatitis. 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 578 employees, operating from its
Mechelen, Belgium headquarters and facilities in the Netherlands,
France, and Croatia. More information at www.glpg.com.
Contact Investors:Elizabeth GoodwinVP IR &
Corporate Communications +1 781 460 1784
Paul van der HorstDirector IR & Business Development +31 71
750 6707ir@glpg.com
Media:Evelyn FoxDirector Communications +31 6 53 591 999
communications@glpg.com
Forward-looking statementsThis release may contain
forward-looking statements, including statements regarding the
potential activity of GLPG2222, GLPG2851, GLPG2451, GLPG2737, or
GLPG3067 (or any combinations thereof), the anticipated timing of
clinical studies with, and plans related to, GLPG2222, GLPG2851,
GLPG2451, GLPG2737, or GLPG3067 (or any combinations thereof), the
timing, progression and/or results (including the reporting
thereof) of such studies and plans, statements regarding
potential triple combination therapies and statements regarding
interactions with regulatory authorities. 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 the ongoing and planned clinical research
programs in CF may not support registration or further development
of GLPG2222, GLPG2851, GLPG2451, GLPG2737, GLPG3067, or potential
triple combination therapies, due to safety, efficacy or other
reasons), Galapagos' reliance on collaborations with third parties
(including its collaboration partner for CF, AbbVie), 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 (SEC) filings and reports, including in
Galapagos' most recent annual report on Form 20-F filed with the
SEC and subsequent 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 marketed product of Vertex
Pharmaceuticals.
[2] Ivacaftor® is a marketed product of Vertex
Pharmaceuticals. Tezacaftor has been submitted for approval by
Vertex.
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