Galapagos to present results for selective JAK1 inhibitor in rheumatoid arthritis patients on 22 November 2011
(Thomson Reuters ONE) -
GLPG0634 preclinical/Phase I poster presentation tomorrow at ACR 2011
Mechelen, Belgium; 7 November 2011- Galapagos NV (Euronext: GLPG) announced
today that it will disclose topline results from the Phase II Proof-of-Concept
trial for GLPG0634, a selective inhibitor of JAK1 (Janus kinase1), in rheumatoid
arthritis patients on 22 November 2011. Financial analysts, investors, and
journalists are invited to attend a webcast press conference to be held at the
Galapagos operations in Leiden, Netherlands, starting at 15.00 CET/9:00 AM
EST/6:00 AM PST.
Preclinical and Phase I clinical results for GLPG0634 will be presented
tomorrow at the American College of Rheumatology Annual Meeting (ACR) taking
place 5-9 November 2011 at McCormick Place in Chicago:
GLPG0634 Shows Selective Inhibition of JAK1 and Maintained JAK-STAT Suppression
in Healthy Volunteers (8-Nov, 9:00 - 11:00 AM, Poster presentation #2210)
The presented data demonstrate that GLPG0634 shows selective JAK1 inhibition,
good safety and maintained JAK1-related biomarker response for up to 10-days
after dosing in healthy volunteers. Biomarker data also show that JAK1 is
inhibited throughout the day for once-daily dosing of GLPG0634 in healthy
volunteers.
The full abstract can be accessed through the ACR website. The poster will be
available in PDF format on Galapagos' website: www.glpg.com.
Details of the Phase II clinical trial
The clinical Proof-of-Concept Phase II trial for GLPG0634 involved 36 patients
with active rheumatoid arthritis, showing an insufficient response to the
standard-of-care treatment, methotrexate (MTX). The aim is to evaluate the
efficacy and safety of GLPG0634 in treating rheumatoid arthritis. Three groups
of 12 patients with moderate to severe disease received either a once- or twice-
daily dose regimen of GLPG0634 or placebo, for a period of four weeks, while all
continued to take a stable background therapy of MTX. The primary efficacy
endpoint will be the ACR20 response rate[1], the standard primary endpoint for
RA clinical trials. Secondary endpoints include improvements in DAS28, ACR50
and ACR70 rates. The safety and tolerability, and the pharmacokinetics of
GLPG0634 in rheumatoid arthritis patients will also be evaluated.
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
signaling 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 trials with an
early onset of action. Galapagos aims to differentiate GLPG0634 from other JAK
inhibitors in development by specifically targeting JAK1, a strategy which could
result in a cleaner safety profile.
GLPG0634 has demonstrated excellent activity in in vitro biochemical studies and
in vivo models of rheumatoid arthritis, and has successfully completed pre-
clinical development and Phase I studies in healthy volunteers.
About Galapagos
Galapagos (Euronext: GLPG; OTC: GLPYY) is a mid-size biotechnology company
specialized in the discovery and development of small molecule and antibody
therapies with novel modes-of-action. The Company is progressing one of the
largest pipelines in biotech, with seven programs in development and over 50
discovery programs. Through risk/reward-sharing alliances with GlaxoSmithKline,
Lilly, Janssen Pharmaceutica, Roche and Servier, Galapagos is eligible to
receive up to ?2.8 billion in downstream milestones, plus royalties. The
Galapagos Group has about 800 employees and operates facilities in six
countries, with global headquarters in Mechelen, Belgium. More info at:
www.glpg.com
CONTACT
Galapagos NV
Elizabeth Goodwin, Director Investor Relations
Tel: +31 6 2291 6240
ir(at)glpg.com
To attend the 22 November event in person at Galapagos' facilities in Leiden,
please register through ir(at)glpg.com.
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.
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[1] ACR20 (American College of Rheumatology 20%) response rate signifies a 20%
or greater improvement in the number of swollen and tender joints as well as a
20% improvement in three out of five other disease-activity measures.
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
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