ALBATROSS with GLPG2222 shows positive clinical results in CF patients
November 19 2017 - 4:01PM
-
Evaluation of C1 corrector GLPG2222 on top of
ivacaftor (Kalydeco®[1]) in
heterozygous Class III/F508del CFTR patients
-
Patient study recruited within 5 months in
Europe and Australia
-
GLPG2222 was well tolerated dosed once daily for
28 days
-
Dose dependent increase in FEV1
-
Statistically significant dose dependent
decreases in sweat chloride
-
Further clinical validation of in vitro predictive platform
Mechelen,
Belgium; 19 November 2017, 22.01 CET - Galapagos NV (Euronext &
NASDAQ: GLPG) reports positive topline results from its ALBATROSS
Phase 2 study in cystic fibrosis patients with C1 corrector
GLPG2222.
The ALBATROSS study included 37
cystic fibrosis patients with a gating (Class III) mutation on one
allele and F508del (Class II) mutation on the other allele. All
patients were on long-term stable Kalydeco treatment (150mg twice
daily) at screening and continued their Kalydeco treatment
throughout the study. The ALBATROSS study was fully recruited
within five months.
Primary objectives of this
randomized, double-blinded, placebo controlled study were to
evaluate the safety and tolerability and pharmacokinetics of novel
C1 corrector GLPG2222 in this CF patient population. Once daily
doses of 150mg GLPG2222, 300mg GLPG2222 or placebo were
administered.
Overall, GLPG2222 was well
tolerated, with observed treatment emergent adverse events being
predominantly mild or moderate, and typical for a CF patient
population. There were no serious adverse events reported and no
discontinuations due to adverse events.
The targeted exposures of GLPG2222
were achieved in this patient study, further strengthening dosing
modelling for the first investigational triple combination.
Exposures achieved in patients were in line with those observed in
healthy volunteers.
The additional activity observed
with treatment with GLPG2222 on top of Kalydeco was in line with
what was observed with tezacaftor combined with Kalydeco in a Phase
2 study in this population. A statistically significant dose
dependent decrease in sweat chloride concentration was observed
amounting to a decrease of 6 mmol/L in the 300mg cohort. Mean
percent predicted FEV1 (ppFEV1) levels overall were 70% at
screening (prior to treatment with GLPG2222). At the end of
treatment with 300mg GLPG2222, ppFEV1 levels increased by 2.2%.
|
Placebo (n=7) |
150mg (n=15) |
300mg (n=14) |
Sweat chloride, mean change D29 vs baseline,
in mmol/L |
+5.6 (3.75^) |
-3.8 (2.55)* |
-6.0 (2.66)* |
ppFEV1, mean change D29 vs baseline,
% |
-0.8% (1.79)
|
-0.6% (1.23) |
+2.2% (1.28) |
* = p<0.05
^= LS-means (SE) from an ANCOVA model with treatment as factor and
baseline as covariate
"The results of this trial are
encouraging as they show that the addition of the novel CFTR
corrector molecule GLPG2222 on top of highly efficacious CFTR
modulator treatment already given for years in patients with gating
mutations was well tolerated and may bring additional benefit to
patients. Also, this clearly demonstrates the interest and
willingness from the CF community to continue develop novel
treatments for patients." commented Prof. Scott Bell from the
Prince Charles Hospital in Brisbane, Australia and principal
investigator for ALBATROSS.
"The ALBATROSS results are the
first results demonstrating that GLPG2222 is well tolerated in CF
patients. In addition, the exposures achieved, coupled with the
activity observed, support our dose selection plans for the
investigational triple combination therapy," said Dr. Piet
Wigerinck, CSO of Galapagos. "We are impressed with the magnitude
of the effects we saw on sweat chloride and FEV1 in patients whose
treatment with ivacaftor has been optimized following years of
therapy."
GLPG2222 is an investigational
therapy; its safety and efficacy have not been established.
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. 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 Goodwin
VP IR & Corporate Communications
+1 781 460 1784
Paul van der Horst
Director IR & Business Development
+31 71 750 6707
ir@glpg.com
Media:
Evelyn Fox
Director Communications
+31 6 53 591 999
communications@glpg.com
Forward-looking
statements
This release may contain forward-looking
statements, including statements regarding the potential activity
of GLPG2222, the anticipated timing of clinical studies with, and
plans related to, GLPG2222, the timing, progression and/or results
of such studies and plans, and statements regarding a potential
triple combination therapy. 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 cystic fibrosis may not support
registration or further development of GLPG2222, or a potential
triple combination therapy, due to safety, efficacy or other
reasons), Galapagos' reliance on collaborations with third parties
(including its collaboration partner for cystic fibrosis, 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]
Kalydeco® is a
registered trademark of Vertex Pharmaceuticals, Inc.
GLPG2222 positive clinical
results
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Source: Galapagos NV via Globenewswire
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