Galapagos selects second component of its investigational cystic fibrosis combination treatment
12 Décembre 2014 - 7:31AM
- Novel corrector GLPG2222 together with
potentiator GLPG1837 offers therapy for most CF patients,
potentially superior to current therapies under development
- Start of Phase 1 with first novel corrector
expected before end 2015
- Final component for triple combination therapy
expected to be nominated in 2015
Mechelen, Belgium; 12 December 2014 - Galapagos NV
(Euronext: GLPG) announced today that it nominated a first
pre-clinical candidate corrector GLPG2222 for clinical development
in its cystic fibrosis (CF) program. This corrector, in combination
with GLPG1837, forms the core of Galapagos' future combination
therapy for the most common mutation in cystic fibrosis. The
Galapagos combination has shown higher efficacy in pre-clinical
studies than other therapies currently under clinical
development.
Identification of novel,
potent, and efficacious corrector candidates is part of
building a triple combination therapy with Galapagos' potentiator
GLPG1837, currently entering Phase 1 safety studies. Galapagos and
AbbVie have developed multiple, novel correctors that in triple
combination with GLPG1837, show >40% restoration of healthy (WT
CFTR) activity in cells derived from CF patients with the delF508
mutation. Furthermore, the Galapagos-AbbVie corrector series
compounds show good drug-like properties, which support further
pre-clinical development. From these series, Galapagos selected a
first pre-clinical candidate, the first corrector building block
which together with potentiator GLPG1837, forms a solid basis for
future triple combination developments. Galapagos is entering Phase
1 with GLPG1837 this month.
"Galapagos and AbbVie have
five different chemical series with several excellent compounds
from which to choose its novel CF correctors. The novel corrector
nominated today forms the second of three ingredients needed for
building our triple combination therapy. This selection brings us a
big step closer to realizing our ambition of developing novel and
best-in-class therapies for CF. The Galapagos-AbbVie team is
working on selecting a second corrector candidate from our series
to augment further the CFTR delF508 levels obtained by the dual
GLPG1837/corrector combination," said Dr Piet Wigerinck, Chief
Scientific Officer of Galapagos.
Galapagos initiated its
research in CF in 2005. In September 2013 Galapagos signed an
agreement with AbbVie in which they will work collaboratively to
develop and commercialize oral drugs that address the main
mutations in CF patients, including F508del and G551D.
About
Cystic Fibrosis
Cystic fibrosis (CF) is
a hereditary disease of the entire body which leads to severe
disability and early death in many cases. Symptoms include frequent
lung infections, sinus infections, poor growth, and diarrhea. The
cause is a defect in a gene which encodes for cystic fibrosis
transmembrane conductance regulator (CFTR), a protein which
regulates components of sweat, mucus, and digestive juices. CF
affects approximately 70,000 people worldwide. Patient symptoms are
treated with antibiotics and other medicines. There currently is no
cure for the disease, and the predicted median age of survival is
in the late 30s. New therapies in development for the main
mutation, delF508 affecting 70% of CF patients, involve combining
two drugs: a corrector to restore the mutation plus a potentiator
to allow efficient opening of the CF channel.
About Galapagos
Galapagos (Euronext: GLPG; OTC: GLPYY) is specialized in novel
modes-of-action, with a large pipeline comprising three Phase 2
studies, two Phase 1 studies, five pre-clinical, and 20 discovery
small-molecule and antibody programs in cystic fibrosis,
inflammation, antibiotics, metabolic disease, and other
indications. In the field of inflammation, AbbVie and Galapagos
signed an agreement for the development and commercialization of
GLPG0634. GLPG0634 is an orally-available, selective inhibitor of
JAK1 for the treatment of rheumatoid arthritis and potentially
other inflammatory diseases, currently in Phase 2B studies in RA
and in Phase 2 in Crohn's disease. Galapagos has another selective
JAK1 inhibitor, GSK2586184 (formerly GLPG0778, in-licensed by
GlaxoSmithKline in 2012). GLPG0974 is the first inhibitor of FFA2
to be evaluated clinically for the treatment of IBD; this program
has completed a Proof-of-Concept Phase 2 study. GLPG1205 is a
first-in-class molecule that targets inflammatory disorders and has
completed Phase 1. GLPG1690 is a first-in-class compound that
targets pulmonary diseases and is currently in a Phase 1 study.
AbbVie and Galapagos signed an agreement in cystic fibrosis to
develop and commercialize molecules that address mutations in the
CFTR gene. Potentiator GLPG1837 is in Phase 1. The first Galapagos
corrector GLPG2222 is at the pre-clinical candidate stage. The
Galapagos Group, including fee-for-service subsidiary Fidelta, has
around 400 employees, operating from its Mechelen, Belgium
headquarters and facilities in The Netherlands, France, and
Croatia. Further information at: www.glpg.com
CONTACT
Galapagos NV
Elizabeth Goodwin, Head of Corporate Communications &
IR
Tel: +31 6 2291 6240
ir@glpg.com
Galapagos
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