Galapagos initiates Phase 1 study with novel CF corrector GLPG3221
November 21 2017 - 4:02PM
- Triggers a $10 million milestone payment from
AbbVie
- Sixth clinical candidate in cystic fibrosis
portfolio
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
CFIn 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 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
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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