MECHELEN, BELGIUM--(Marketwired - July 02, 2013) -
* GLPG1205 is a first-in-class molecule to enter the clinic
* Candidate drug targets inflammation of the bowel
* Galapagos receives EUR6.6 million milestone payment
Galapagos NV (Euronext: GLPG) announced today that it has initiated a
First-in-Human (FIH) Phase 1 study with GLPG1205 as part of its alliance
with Janssen Pharmaceutica NV. This achievement triggered a milestone
payment of EUR6.6 million to Galapagos, which will contribute to H1
In 2007, Galapagos announced an alliance agreement with Janssen
providing the option to worldwide, commercial licenses to certain
internal inflammatory disease programs. These programs include a novel
for inflammatory disorders that was identified and validated by Galapagos
its proprietary target discovery engine. Subsequent Galapagos research
the discovery of GLPG1205, a first-in-class molecule that enters the
inflammatory disorders. Galapagos will be responsible for execution of
and Phase 2A studies with GLPG1205.
"With GLPG1205, Galapagos has moved another proprietary molecule with a
mode-of-action into the clinic. This program has the potential to unlock
class of drugs to treat inflammatory disorders. Consistent with our
bringing innovative molecules to the clinic, this is the fourth First-in-
study with a novel mode-of-action," said Onno van de Stolpe, CEO of
"The alliance with Janssen is the second where Galapagos has brought
from target to the clinic. Today's achievement brings Galapagos'
five clinical programs, and we are pleased we will be driving the Phase
2A studies forward with this potential new therapy in inflammatory
The aim of this FIH study is to evaluate the safety,
pharmacokinetics, and pharmacodynamics of oral single and multiple
doses of GLPG1205. The randomized, double-blind, placebo-controlled,
center study will be conducted in 40 healthy volunteers in Belgium.
first part of the study, single ascending doses will be evaluated.
second part, the new compound will be administered daily for 14 days.
expects to disclose topline results from the study by the end of this year.
Galapagos (Euronext: GLPG; OTC: GLPYY) is specialized in novel modes-of-
with a large pipeline of five clinical, six pre-clinical, and 30
small-molecule and antibody programs in cystic fibrosis,
antibiotics, metabolic disease, and other indications.
GLPG0634 is an orally-available, selective inhibitor of JAK1 for the
of rheumatoid arthritis and potentially other inflammatory diseases,
in Phase 2B studies in RA and about to enter Phase 2 studies in
disease. AbbVie and Galapagos signed a worldwide license agreement
AbbVie will be responsible for further development and commercialization
Phase 2B. Galapagos has another selective JAK1 inhibitor in Phase 2 in
and psoriasis, GSK2586184 (formerly GLPG0778, in-licensed by
2012). GLPG0187 is a novel integrin receptor antagonist currently in a
1B patient study in metastasis. GLPG0974 is the first inhibitor of FFA2
evaluated clinically for the treatment of IBD; this program is currently
Proof of Concept Phase 2 study. GLPG1205 is a first-in-class molecule
targets inflammatory disorders and is currently in a First-in-Human
The Galapagos Group, including fee-for-service companies BioFocus,
Fidelta, has 800 employees and operates facilities in five countries,
global headquarters in Mechelen, Belgium. Further information at:
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,"
"stands to," and "continues," as well as similar expressions. Such forward-
looking statements may involve known and unknown risks, uncertainties and
factors which might cause the actual results, financial condition,
or achievements of Galapagos, or industry results, to be materially
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
such forward-looking statements. These forward-looking statements speak
of the date of publication of this document. Galapagos expressly disclaims
obligation to update any such forward-looking statements in this document
reflect any change in its expectations with regard thereto or any change in
events, conditions or circumstances on which any such statement is based,
required by law or regulation.
Galapagos initiates Phase 1 trial:
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Galapagos NV via Thomson Reuters ONE