Galapagos doses first healthy volunteer with CF combo GLPG2222 and GLPG2451
(Thomson Reuters ONE) -
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 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 $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 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 Director Communications
Communications +31 6 53 591 999
+1 781 460 1784 communications(at)glpg.com
Paul van der Horst
Director IR & Business
Development
+31 6 53 725 199
ir(at)glpg.com
Forward-looking statements
This 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.
GLPG starts Ph1 CF combo:
http://hugin.info/133350/R/2081667/784173.pdf
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
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