Galapagos doses first healthy volunteer with CF combo GLPG2222 and GLPG2451
February 23 2017 - 4:01PM
Mechelen, Belgium; 23 February 2017 - Galapagos
NV (Euronext & NASDAQ: GLPG) announces dosing of the first
healthy volunteer with a combination of novel corrector GLPG2222
and novel potentiator GLPG2451 for cystic fibrosis in a Phase 1
study.
After completion of the dosing of GLPG2451 as a
monotherapy, in the new cohorts the safety, tolerability and PK of
14 days co-administration of GLPG2451 and GLPG2222 is being
evaluated. The randomized, double-blind, placebo controlled, single
center study is being conducted in at least 40 healthy volunteers
in Belgium.
In order to bring a more effective therapy to
the majority of cystic fibrosis patients, Galapagos and AbbVie have
a portfolio of candidates addressing three complementary components
for a potential combination therapy. In the present study,
potentiator GLPG2451 and C1 corrector GLPG2222 are evaluated as
potential components of this triple combination.
Triple combinations of CF compounds in the
portfolio have consistently shown restoration of healthy activity
levels in in vitro assays with human bronchial epithelial (HBE)
cells of patients with the F508del mutation. These combinations
result in an increase in chloride transport compared to Orkambi[1]
in HBE cells with the homozygous F508del mutation.
"We are pleased to have initiated our first dual
combo Phase 1 study with our potentiator and C1 corrector for
cystic fibrosis," said Dr Piet Wigerinck, CSO of Galapagos. "This
step brings us closer to our goal of initiating a patient
evaluation of a triple combination therapy by mid-2017."
About the Galapagos-AbbVie collaboration in
cystic fibrosisIn September 2013 Galapagos and AbbVie entered
into a global collaboration agreement focused on the discovery and
worldwide development and commercialization of potentiator and
corrector molecules for the treatment of CF. Under the terms of the
agreement, AbbVie made an upfront payment of $45 million to
Galapagos. Upon successful completion by Galapagos of clinical
development through to completion of Phase 2, AbbVie will be
responsible for Phase 3, with financial contribution by Galapagos.
Galapagos has earned $50 million in milestone payments to date and
is still eligible to receive up to approximately $550 million in
total payments for developmental and regulatory milestones, sales
milestones upon the achievement of minimum annual net sales
thresholds and additional tiered royalty payments on net sales,
ranging from mid-teens to 20%. Galapagos has commercial rights to
China and South Korea, and has an option to co-promote in Belgium,
Netherlands, and Luxembourg.
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 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 510
employees, operating from its Mechelen, Belgium headquarters and
facilities in The Netherlands, France, and Croatia. More
information at www.glpg.com.
Contacts
Investors: |
Media: |
Elizabeth Goodwin |
Evelyn
Fox |
VP IR
& CorporateCommunications+1 781 460 1784 |
Director
Communications +31 6 53 591 999 communications@glpg.com |
Paul van der HorstDirector IR & BusinessDevelopment+31 6 53 725
199 |
|
ir@glpg.com |
|
Forward-looking statementsThis release may contain
forward-looking statements, including statements regarding
Galapagos' strategic ambitions, the potential efficacy of
Galapagos' product candidates in cystic fibrosis (including
GLPG2222 and GLPG2451), the anticipated timing of clinical studies
with GLPG2222, GLPG2451 (or combinations thereof) and Galapagos'
other cystic fibrosis product candidates, and the progression and
results of such studies and statements regarding a potential triple
combination therapy in cystic fibrosis. 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 may not support registration or further development of
Galapagos' product candidates 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]Orkambi® is a prescription medicine sold by Vertex
Pharmaceuticals, used for the treatment of cystic fibrosis (CF) in
patients age 12 years and older who have two copies of the F508del
mutation (F508del/F508del) in their CFTR gene.
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