ALBATROSS with GLPG2222 shows positive clinical results in CF patients
20 November 2017 - 8:02AM
- 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 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.
ContactInvestors: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, 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.
Attachments:
http://www.globenewswire.com/NewsRoom/AttachmentNg/c06d67f1-4b0e-4a85-b12c-b364875a8ac3
Galapagos NV (NASDAQ:GLPG)
Historical Stock Chart
From Apr 2024 to May 2024
Galapagos NV (NASDAQ:GLPG)
Historical Stock Chart
From May 2023 to May 2024