Galapagos initiates Phase 1 study with novel CF corrector GLPG3221
November 21 2017 - 4:01PM
Mechelen,
Belgium; 21 November 2017; 22.01 CET -Galapagos NV (Euronext & NASDAQ: GLPG) announces initiation of a Phase 1 study with a novel C2
corrector GLPG3221 for cystic fibrosis (CF). Galapagos receives a
$10 million milestone payment from its collaboration partner AbbVie
for this achievement.
The aim of the Phase 1 study is to
evaluate the safety, tolerability and pharmacokinetics of GLPG3221
in healthy volunteers. The randomized, double-blind, placebo
controlled, single centre study is being conducted in Belgium.
Topline results from this Phase 1 study are expected to be
disclosed at a future medical conference.
In order to bring a more effective
therapy to the majority of CF patients, Galapagos and AbbVie have a
large portfolio of candidates addressing three complementary
components for a potential combination therapy. GLPG3221 is the
second C2 corrector, chemically distinct from the first C2
corrector. It will form part of a triple combo expected to be
tested in patients next year. Galapagos expects to initiate the
first triple combo patient study (including the first C2 corrector)
later this quarter.
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 have resulted in an increase
in chloride transport compared to Orkambi[1] and
tezacaftor+ivacaftor in HBE cells with the homozygous and
heterozygous F508del mutation.
"We are pleased to add GLPG3221 to
our growing list of clinical CF candidates," said Dr Piet
Wigerinck, CSO of Galapagos. "We plan to initiate further studies
within our CF portfolio, in parallel to running our first patient
evaluation of a triple combo starting later this year."
GLPG3221 is an investigational
therapy; its safety and efficacy have not been established.
About the
Galapagos-AbbVie collaboration in CF
In 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 $67 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,
the Netherlands, and Luxembourg.
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 composition of a
potential triple combination therapy for CF, the potential efficacy
of Galapagos' compounds in cystic fibrosis, the anticipated timing
of clinical studies with the cystic fibrosis portfolio of candidate
drugs, and the progression and results of such studies. 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 a potential
triple combination, any of Galapagos' potentiators or correctors
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.
¹Orkambi® is a marketed
product of Vertex Pharmaceuticals
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The issuer of this announcement warrants that they are solely
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information contained therein.
Source: Galapagos NV via Globenewswire
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