SAPHIRA 1 topline shows competitive clinical results in G551D patients
December 20 2016 - 4:07PM
- First potentiator after Kalydeco®[1] to show comparable results
in G551D patients
- GLPG1837 was generally well tolerated when dosed up to 500 mg
twice daily for 14 days
- Statistically significant and dose dependent decreases in sweat
chloride observed
- 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 presentationGalapagos
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
|
|
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 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. 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 |
|
VP IR
& Corporate Communications |
|
+1 781
460 1784 Paul van der HorstDirector 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 statementsThis 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
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