Galapagos selects pre-clinical candidate for cystic fibrosis
December 16 2013 - 12:37AM
- Novel potentiator shows more activity in pre-clinical
studies than market leader Kalydeco ®
- Start of Phase 1 expected before end 2014
Galapagos NV (Euronext: GLPG) announced today that it
nominated a pre-clinical candidate potentiator for clinical
development in its cystic fibrosis (CF)
program.
Galapagos has developed multiple, novel
potentiators that, in pre-clinical research, show high potency and
superior efficacy in comparison to Kalydeco® (ivacaftor),the only
approved disease-modifying CF drug on the market today.
Furthermore, the Galapagos compounds show good drug-like
properties, which support further pre-clinical development. The
clean safety profile[1] of these compounds should allow the
combination with antibiotics frequently prescribed for CF
patients. From these series, Galapagos selected GLPG1837 as
pre-clinical candidate and expects to start the first clinical
trial before end 2014. Galapagos recently filed a patent
application covering GLPG1837, with the expected patent life until
at least 2034.
"Galapagos had several excellent compounds to choose from among
its novel CF potentiators. GLPG1837 forms the first part of
our strategy to develop novel and best-in-class therapies for
CF. The Galapagos-AbbVie team is now fully ramped up to
progress our correctors, which are needed in combination with the
potentiator to address the unmet need of most CF patients," said Dr
Piet Wigerinck, Chief Scientific Officer of Galapagos.
Galapagos initiated its research in CF in 2005
as part of a collaboration with the Cystic Fibrosis
Foundation. 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. Under the terms of the
agreement, AbbVie made an upfront payment of $45 million to
Galapagos. Upon successful completion of pre-determined
success milestones, AbbVie and Galapagos will share responsibility
and funding for Phase III clinical development. Galapagos is
eligible to receive up to $360 million in total additional payments
for developmental and regulatory milestones, sales milestones upon
the achievement of minimum annual net sales thresholds and
additional double-digit royalty payments on net sales.
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 of six Phase 2 studies (three led by GSK), one
Phase 1 study, five pre-clinical, and 20 discovery small-molecule
and antibody programs in cystic fibrosis, inflammation,
antibiotics, metabolic disease, and other indications. AbbVie and
Galapagos signed an agreement in CF where they work collaboratively
to develop and commercialize oral drugs that address two mutations
in the CFTR gene, the G551D and F508del mutation. Potentiator
GLPG1837 is at the pre-clinical candidate stage. In the field of
inflammation, AbbVie and Galapagos signed a worldwide license
agreement whereby AbbVie will be responsible for further
development and commercialization of GLPG0634 after Phase 2B.
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
about to enter Phase 2 studies in Crohn's disease. Galapagos
has another selective JAK1 inhibitor in Phase 2 in ulcerative
colitis, psoriasis, and lupus, 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 is currently in a Proof-of-Concept
Phase 2 study. GLPG1205 is a first-in-class molecule that
targets inflammatory disorders and has completed Phase 1 studies.
The Galapagos Group, including fee-for-service companies BioFocus,
Argenta and Fidelta, has around 800 employees and operates
facilities in five countries, with global headquarters in Mechelen,
Belgium. Further information at: www.glpg.com
Contact
Elizabeth Goodwin, Director Investor Relations
Tel: +31 6 2291 6240 ir@glpg.com
Galapagos forward-looking statements This
release may contain forward-looking statements, including, without
limitation, statements containing the words "believes,"
"anticipates," "expects," "intends," "plans," "seeks," "estimates,"
"may," "will," "could," "stands to," and "continues," as well as
similar expressions. Such forward-looking statements may involve
known and unknown risks, uncertainties and other factors which
might cause the actual results, financial condition, performance or
achievements of Galapagos, or industry results, to be materially
different from any historic or future results, financial
conditions, performance or achievements expressed or implied by
such forward-looking statements. 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,
unless required by law or regulation.
Kalydeco® is a registered trademark of Vertex
Pharmaceuticals Incorporated [1] supported by high selectivity, and
the absence of CYP inhibition
HUG#1749994
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