Galapagos' GLPG0634 shows excellent efficacy and safety in rheumatoid arthritis Phase II study
(Thomson Reuters ONE) -
* Statistically significant improvement already seen in four weeks:
* 83% of patients showed improvement in ACR20 score
o half of treated patients went into remission or showed a low disease
activity
· Unique and clean safety profile: neither anemia nor increase in
LDL/cholesterol observed
* First JAK1 selective compound to demonstrate clinical efficacy
* Achievement of 2011 revenue and profit guidance depends on partnering of the
program
Webcast press conference presentation at 15.00 Central European Time (CET)/9:00
AM EST, www.glpg.com, call number +32 2290 1608
Mechelen, Belgium; 22 November 2011- Galapagos NV (Euronext: GLPG) announced
that its JAK1 inhibitor, GLPG0634, achieved the primary endpoint of significant
improvement in the signs and symptoms of rheumatoid arthritis (RA). GLPG0634 is
a selective inhibitor of JAK1 (Janus kinase 1) being developed for inflammatory
conditions, such as rheumatoid arthritis (RA).
Efficacy results at week four
+------------------+-------+---------------------------+------------------+
| | | GLPG0634 | |
| |Placebo| |Pooled vs. placebo|
| | n=12 |100 mg BID 200 mg QD Pooled| |
| | | n=12 n=12 n=24 | |
+------------------+-------+----------+---------+------+------------------+
|ACR20 (%) | 33.3 | 91.7 | 75.0 | 83.3 | p=0.0067 |
+------------------+-------+----------+---------+------+------------------+
|ACR50 (%) | 8.3 | 58.3 | 25.0 | 41.7 | p=0.0591 |
+------------------+-------+----------+---------+------+------------------+
|ACR70 (%) | 0 | 25.0 | 16.7 | 20.8 | ns |
+------------------+-------+----------+---------+------+------------------+
|DAS28 (change) |- 0.20 | - 2.98 | - 2.28 |- 2.63| p<0.0001 |
+------------------+-------+----------+---------+------+------------------+
|CRP (change, mg/L)| 21.9 | - 13.8 | - 35.0 |- 24.4| p<0.0001 |
+------------------+-------+----------+---------+------+------------------+
In this four week, Proof-of-Concept trial in 36 RA patients, GLPG0634 was
administered in two dosage arms of 200 mg: one group taking a once-daily dose
(QD), and the other taking twice-daily doses of 100 mg (BID). GLPG0634 met the
primary endpoint of significant improvement in ACR20[1] response rate and showed
impressive results in secondary efficacy endpoints: ACR50, ACR70, DAS28[2] and
CRP (C-reactive protein). GLPG0634 was well-tolerated, with all patients
completing the trial and no safety signals reported. No anemia or increases in
lipids (LDL or cholesterol) were observed in this trial. No severe adverse
events were reported in patients receiving GLPG0634.
"We noticed a rapid and remarkable response for the RA patients participating in
this trial, with no treatment-emergent safety signals arising," said Minodora
Mazur, MD, PhD, Professor Internal Medicine & Rheumatology, State Medical and
Pharmaceutical University "Nicolae Testemitanu" and Principal Investigator for
the trial. "Patients did very well while on therapy - in fact, many reported
significant improvements after one week of treatment."
"Despite the short duration of the trial, GLPG0634 shows one of the highest
initial response rates ever reported for rheumatoid arthritis treatments. If
this efficacy and safety profile is maintained in longer treatment studies,
GLPG0634 has the potential to become a blockbuster treatment for RA and other
inflammatory diseases," said Piet Wigerinck, Senior Vice President Development
of Galapagos.
"Galapagos identified the JAK1 target with its proprietary target discovery
platform back in 2003, well before JAK inhibitors were evaluated clinically.
Since then, we have developed the target all the way into GLPG0634. This
clearly demonstrates the power of our target and drug discovery capabilities and
validates our innovative approach," said Onno van de Stolpe, CEO of Galapagos.
Galapagos plans to initiate an extended dose-range finding study for GLPG0634 in
the first half of 2012. This will further define the optimal doses for efficacy
and safety to be evaluated in longer term studies in patients. GLPG0634 is a
fully proprietary program.
Galapagos has given 2011 financial guidance for the Group of ?146 million in
revenues, a positive operational result and cash flow and a positive net
result. This guidance will only be achievable in the event the GLPG0634 program
is successfully partnered before year end. Galapagos is in discussions with a
number of pharma partners regarding the program, but the Company has not yet
decided whether or not to partner, and on which conditions. This important
choice will be made with a focus on maximizing the long term value for
shareholders.
Conference call and webcast presentation
Galapagos will conduct a conference call today, 22 November 2011, at 15.00
Central European Time (CET)/9:00 AM EST, which will also be webcast (view
webcast). To participate in the conference call or the question and answer
session following the presentation, please call +32 2290 1608 ten minutes prior
to commencement. The archived webcast also will be available for replay shortly
after the close of the call.
Details of the Phase II clinical trial
The clinical Proof-of-Concept Phase II trial (study identifier: NCT01384422,
Eudract: 2010-022953-40) for GLPG0634 involved 36 patients with active
rheumatoid arthritis, showing an insufficient response to the standard-of-care
treatment, methotrexate (MTX). The aim of this study was to evaluate the
efficacy and safety of GLPG0634 in patients with active rheumatoid arthritis.
Three groups of 12 patients with moderate to severe disease received either a
200 mg once-daily or a 100 mg twice-daily dose regimen of GLPG0634 or placebo,
for a period of four weeks, while continuing to take their stable background
therapy of MTX and other low-dose anti-inflammatory drugs. The primary efficacy
endpoint was the ACR20 response rate, the standard primary endpoint for early RA
clinical trials. Secondary endpoints included improvements in ACR50, ACR70 and
DAS28 rates. The safety, tolerability, pharmacokinetics and pharmacodynamics of
GLPG0634 in RA patients were also 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. Other
nonselective JAK inhibitors have shown long-term efficacy in rheumatoid
arthritis trials with an early onset of action. Galapagos aimed to
differentiate GLPG0634 from other JAK inhibitors in development by specifically
targeting JAK1, a strategy which could result in a cleaner safety profile, as
the data of this Proof-of-Concept study supports.
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 GLPG0634, as
well as 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
Onno van de Stolpe, CEO
Tel: +31 6 2909 8028
Piet Wigerinck, SVP Development
Tel: +32 477 62 7103
Elizabeth Goodwin, Director Investor Relations
Tel: +31 6 2291 6240
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.
--------------------------------------------------------------------------------
[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% or greater improvement in three out of five other disease-activity measures.
[2] DAS28 is an RA Disease Activity Score based on C-reactive protein, tender
and swollen joint counts of 28 defined joints and physician's global health
assessment; a total score of >5.1 is associated with high disease activity,
moderate from 3.2 to 5.1, low disease activity from 2.6, and remission of
disease if <2.6.
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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