Galapagos selects second component of its investigational cystic fibrosis combination treatment
December 12 2014 - 1:38AM
- 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
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
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