Galapagos presents scope of GLPG0634 Phase 2b program
(Thomson Reuters ONE) -
* AbbVie provides additional funding of $20 million to Galapagos for Phase 2b
program expansion
* Phase 2b program in RA to include 875 patients
Mechelen, Belgium; 16 April 2013 - Galapagos NV (Euronext: GLPG) announced an
expansion of the Phase 2b program with GLPG0634 in rheumatoid arthritis (RA).
Galapagos wil increase the number of patients in the Phase 2b program to 875.
AbbVie will provide an additional payment of $20 million to Galapagos prior to
the start of the Phase 2b program in RA to fund the program's expansion to 875
patients.
GLPG0634 is the first selective JAK1 inhibitor in development for autoimmune
diseases. In February 2012, Galapagos and AbbVie announced a global
collaboration for GLPG0634 to treat autoimmune diseases. In November 2011
Galapagos announced promising efficacy and safety in a 4 week Proof of Concept
study in RA. The results of the 4-week Phase 2a clinical study repeated the
clinical benefit and safety of the drug seen in the Proof of Concept study.
Galapagos will initiate a 24-week global Phase 2b program in RA in Q2 2013, with
trial design finalized by both Galapagos and AbbVie. The total number of
patients to be included in the Phase 2b program will be expanded to 875, which
will facilitate a final dose and regimen selection for Phase 3 clinical studies.
Galapagos expects to report topline data from the Phase 2b program in Q4 2014.
The scope of the Phase 2 'Darwin' studies is as follows:
+-------------------------------+
| Darwin 1 - Add-on to MTX |
+------------+------------------+
| 200 mg QD | 85 patients (pt) |
+------------+------------------+
| 100 mg QD | 85 pt |
+------------+------------------+
| 50 mg QD | 85 pt |
+------------+------------------+
| 100 mg BID | 85 pt |
+------------+------------------+
| 50 mg BID | 85 pt |
+------------+------------------+
| 25 mg BID | 85 pt |
+------------+------------------+
| Placebo | 85 pt |
+------------+------------------+
| TOTAL | 595 pt |
+------------+------------------+
+------------------------------+
| Darwin 2 - Monotherapy |
+-----------+------------------+
| 200 mg QD | 70 patients (pt) |
+-----------+------------------+
| 100 mg QD | 70 pt |
+-----------+------------------+
| 50 mg QD | 70 pt |
+-----------+------------------+
| Placebo | 70 pt |
+-----------+------------------+
| TOTAL | 280 pt |
+-----------+------------------+
"We welcome AbbVie's support for expanding the GLPG0634 Phase 2b program in RA.
This will optimize the program to explore the once- and twice-daily dosing
profile of GLPG0634. The program is on track, with the start of the Phase 2b
trials in this quarter. We benefit from the growing experience with JAK
inhibitors in clinical development and on the market, which has helped us to
design data-rich studies, preparing an efficient continuation into pivotal
studies in Phase 3," said Onno van de Stolpe, CEO of Galapagos.
About candidate drug GLPG0634
GLPG0634 is an orally-available, novel Janus kinase (JAK) inhibitor with
selectivity for JAK1 developed by Galapagos. JAKs are critical components of
signalling mechanisms utilized by a number of cytokines and growth factors,
including those that are elevated in rheumatoid arthritis patients. JAK
inhibitors have shown long-term efficacy in rheumatoid arthritis studies with an
early onset of action. GLPG0634 differentiates from other JAK inhibitors in
development by specifically targeting JAK1, a strategy which could result in a
better efficacy and safety profile. GLPG0634 is a fully proprietary program.
Upon successful completion of the RA Phase 2b studies, AbbVie will license the
program and will assume sole responsibility for Phase 3 clinical development and
global manufacturing.
About Galapagos
Galapagos (Euronext: GLPG; OTC: GLPYY) is specialized in novel modes-of-action,
with a large pipeline of four clinical, six pre-clinical, and 30 discovery
small-molecule and antibody programs in cystic fibrosis, inflammation,
antibiotics, metabolic disease, and other indications.
GLPG0634 is an orally-available, selective inhibitor of JAK1 for the treatment
of rheumatoid arthritis and potentially other inflammatory diseases, about to
enter Phase 2b studies. AbbVie and Galapagos signed a worldwide license
agreement whereby AbbVie will be responsible for further development and
commercialization after Phase 2b. Galapagos has another selective JAK1
inhibitor in Phase 2 in lupus and psoriasis, GSK2586184 (formerly GLPG0778, in-
licensed by GlaxoSmithKline in 2012). GLPG0187 is a novel integrin receptor
antagonist currently in a Phase 1b patient study in metastasis. GLPG0974 is the
first inhibitor of GPR43 to be evaluated clinically for the treatment of IBD;
this program will start a Proof of Concept Phase 2 study in Q2 2013.
The Galapagos Group, including fee-for-service companies BioFocus, Argenta and
Fidelta, has 800 employees and operates facilities in five countries, with
global headquarters in Mechelen, Belgium. Further information at: www.glpg.com
Contact
Galapagos NV
Onno van de Stolpe, Chief Executive Officer
Tel. +31 6 2909 8028
Elizabeth Goodwin, Director Investor Relations
Tel: +31 6 2291 6240
ir(at)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.
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
[HUG#1693470]
Unternehmensinformation / Kurzprofil:
Datum: 16.04.2013 - 18:02 Uhr
Sprache: Deutsch
News-ID 249665
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contact information:
Town:
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