SAPHIRA 1 topline shows competitive clinical results in G551D patients
December 20 2016 - 4:00PM
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First potentiator after Kalydeco®[1] to show
comparable results in G551D patients
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GLPG1837 was generally well tolerated when dosed
up to 500 mg twice daily for 14 days
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Statistically significant and dose dependent
decreases in sweat chloride observed
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Clinical validation of in
vitro predictive platform
Webcast presentation tomorrow (21 Dec) at 15.00 CET/9 AM
ET, www.glpg.com,
+ 32 2 404 0659, code
6588087
Mechelen,
Belgium; 20 December 2016 - Galapagos NV (Euronext & NASDAQ:
GLPG) reports topline results from its SAPHIRA 1 Phase 2 study in
cystic fibrosis patients with potentiator GLPG1837.
The SAPHIRA 1 trial included 26
patients with the G551D mutation in CFTR each receiving three
sequential doses of GLPG1837. Of these, 25 patients were on stable
Kalydeco treatment at screening and agreed to a one week washout
prior to the start of dosing GLPG1837. One patient was naïve to
Kalydeco. All subjects received GLPG1837 125 mg bid (twice-daily)
for 7 days, immediately followed by 250 mg bid for 7 days and
subsequently by 500 mg bid for 14 days.
A statistically significant dose
dependent decrease in sweat chloride concentration was observed. At
the 500 mg bid dose, sweat chloride decreased from a mean value of
98 mmol/L at baseline to 66 mmol/L (p <0.0001). For those
patients exceeding the predicted target concentration, sweat
chloride changed from a mean value of 94 mmol/L at baseline to 52
mmol/L.
25 patients were on stable
treatment with Kalydeco prior to this study. For these patients,
mean percent predicted FEV1 (ppFEV1) levels were 74% at screening
(prior to Kalydeco washout). The one week wash-out resulted in a
5.4% mean decrease in absolute ppFEV1. At the end of treatment with
GLPG1837, the ppFEV1 levels returned to the Kalydeco pre-washout
levels.
Overall GLPG1837 was well
tolerated, with observed treatment emergent adverse events being
predominantly mild or moderate, and typical for a CF patient
population. One patient dropped out of the study due to an increase
in non-cardiac creatine phosphokinase.
"The success of this trial is an
important milestone in two regards; firstly, GLPG1837 has shown
safety and significant efficacy as a novel CFTR potentiator.
Secondly, it demonstrates that the CF community is committed to the
further development of CFTR modulators despite the complexities
related to evolving standards of care," commented Prof Jane Davies
of the Royal Brompton & Harefield NHS Trust in London and
principal investigator for SAPHIRA 1.
"The SAPHIRA 1 results show this
is the first new potentiator since Kalydeco to demonstrate
competitive results in patients harboring the G551D mutation.
Galapagos has a suite of potentiators in development. Galapagos and
AbbVie will further study the data before deciding which
potentiator will be included in the triple combination," said Dr
Piet Wigerinck, CSO of Galapagos. "The clinical validation of our
in vitro systems reinforces our belief in our
approach to get to a triple combination therapy."
Conference call and webcast presentation
Galapagos will conduct a conference call and webcast open to the
public tomorrow (21 December 2016) at 15:00 Central European Time
(CET) or 9 AM ET. To participate in the conference call, please
call one of the following numbers ten minutes prior to
commencement:
CODE: 6588087
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|
UK: |
+44 330 336 9105 |
Netherlands: |
+31 20 721 9251 |
France: |
+ 33 1 76 77 22 74 |
Belgium: |
+ 32 2 404 0659 |
USA: |
+1 719 325 4746 |
|
|
A question and answer session will
follow the presentation of the results. 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 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. Our
pipeline comprises a pipeline of 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 480
employees, operating from its Mechelen, Belgium headquarters and
facilities in The Netherlands, France, and Croatia. More
information at www.glpg.com.
Contacts
|
|
Elizabeth
Goodwin |
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VP IR &
Corporate Communications |
|
+1 781 460
1784
Paul van der Horst
Director 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
statements
This release may contain forward-looking
statements, including statements regarding the potential activity
of GLPG1837, the anticipated timing of clinical studies with
GLPG1837, the progression and results of such studies, 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 GLPG1837 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
marketed drug of Vertex Pharmaceuticals
This
announcement is distributed by Nasdaq Corporate Solutions on behalf
of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: Galapagos NV via Globenewswire
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