Galapagos initiates Phase 1 study with novel CF potentiator GLPG3067
(Thomson Reuters ONE) -
* Triggers a $7.5 M milestone payment from AbbVie
* Third potentiator in growing portfolio of cystic fibrosis drug candidates
Mechelen, Belgium; 22 March 2017, 7.30 CET -Galapagos NV (Euronext & NASDAQ:
GLPG) announces initiation of a Phase 1 study with novel potentiator GLPG3067
for cystic fibrosis (CF) in a Phase 1 study. Galapagos is to receive a $7.5
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 oral single and multiple ascending doses of GLPG0367. The
safety and tolerability of the combination of GLPG3067 and GLPG2222 will also be
evaluated. The randomized, double-blind, placebo controlled, single centre study
is being conducted in at least 48 healthy volunteers in Belgium. In the first
part of the study, single ascending doses of GLPG3067 will be evaluated. In the
second part, multiple ascending doses will be administered daily for 14 days. In
the last part of the study the combination of GLPG3067 and GLPG2222 will be
administered for 14 days. 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 cystic fibrosis
patients, Galapagos and AbbVie have a portfolio of candidates addressing three
complementary components for a potential combination therapy. Galapagos is
currently testing potentiator GLPG2451 and corrector GLPG2222 in healthy
volunteers. The aim is to add corrector GLPG2737 to make a triple combination,
which will first be evaluated in healthy volunteers and then in patients with
the F508del mutation.
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 continue to explore additional molecules to enrich our growing portfolio of
cystic fibrosis drug candidates," said Dr Piet Wigerinck, CSO of Galapagos. "We
plan to initiate multiple studies within our CF portfolio in the course of this
year, as we get closer to our goal of initiating a patient evaluation of a
triple combination therapy by mid-2017."
About the Galapagos-AbbVie collaboration in cystic fibrosis
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 $57
million in milestone payments to date and is still eligible to receive up to
approximately $560 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 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 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 & Corporate Communications Director Communications
+1 781 460 1784 +31 6 53 591 999
communications(at)glpg.com
Paul van der Horst
Director IR & Business Development
+31 6 53 725 199
ir(at)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 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.
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¹Orkambi(®) is a marketed product 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
Unternehmensinformation / Kurzprofil:
Datum: 22.03.2017 - 07:31 Uhr
Sprache: Deutsch
News-ID 531662
Anzahl Zeichen: 9266
contact information:
Town:
Mechelen
Kategorie:
Business News
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