Primary endpoint achieved with ziritaxestat in NOVESA trial in systemic sclerosis patients
September 10 2020 - 10:30PM
Mechelen, Belgium; 11 September 2020,
04.30 CET – Galapagos NV (Euronext & NASDAQ: GLPG) reports
positive topline results in the NOVESA Phase 2a clinical trial with
investigational ziritaxestat (GLPG1690) in patients with diffuse
cutaneous systemic sclerosis (dcSSc).
Ziritaxestat reached the primary endpoint of the
study with a statistically significant change from baseline in the
modified Rodnan Skin Score (mRSS) at Week 24, of -8.3 vs -5.7 for
placebo.
|
600 mg ziritaxestat, n=21 |
placebo,n=12 |
Mean baseline mRSS (standard deviation) |
27.0 (8.8) |
22.5 (6.2) |
Mean change from baseline (standard error) at Week 24,
p-value1 |
-8.3 (1.2), p=0.0411 |
-5.7 (1.7) |
NOVESA is a double-blind, placebo-controlled
Phase 2a proof-of-concept trial evaluating the efficacy, safety and
tolerability of ziritaxestat (GLPG1690) in 33 patients with dcSSc.
DcSSc is a severe autoimmune disease with one of the highest
mortality rates among rheumatic diseases2 with no drugs currently
approved to treat the overall disease. Systemic sclerosis (SSc)
affects approximately 124,000 people3 in the US and Europe4, with a
predominance of female patients (>80%).
Patients recruited for NOVESA included mostly
females (70%) around 50 years old, with a mean disease duration of
1.9 years. Most patients enrolled were on a background
immunosuppressant therapy during the course of the study.
Ziritaxestat was generally well tolerated. No
deaths were reported in this study. Two patients taking
ziritaxestat experienced serious adverse events versus one patient
in the placebo group. Both patients in the ziritaxestat group
recovered fully and are still participating in the long-term
extension trial.
94% of patients (31 of the 33) who completed the
NOVESA trial continued in the long-term open label extension
trial.
“We are excited to see that after showing
promising activity in the phase 2 FLORA trial in idiopathic
pulmonary fibrosis, ziritaxestat achieved statistically significant
improvements in mRSS in diffuse SSc, the primary endpoint in the
NOVESA study. Keeping in mind that this is our first study in SSc
and that the impact on skin is difficult to measure on a background
treatment with immunosuppressants, we are pleased with the results
reported today. We will now further analyze the NOVESA data to
determine next steps in SSc, a disease with important unmet medical
need,” said Dr Walid Abi-Saab, Chief Medical Officer of
Galapagos.
Detailed results from the NOVESA trial will be
presented at future medical conferences.
Ziritaxestat is an investigational drug and not
approved by any regulatory authority. Its efficacy and safety have
not been established.
About ziritaxestatZiritaxestat
is a small molecule, selective autotaxin inhibitor co-developed
with Gilead Sciences, Inc. as part of the global collaboration
between Galapagos & Gilead. Autotaxin is the main enzyme
responsible for lysophosphatidic acid (LPA) production. LPA is a
well-known pro-fibrotic and pro-inflammatory lipid, acting through
at least 6 g-protein coupled receptors. Galapagos identified the
autotaxin target using its proprietary target discovery platform
and developed molecule ziritaxestat as an inhibitor of this target.
Ziritaxestat has orphan drug designation from the US and EU in both
idiopathic pulmonary fibrosis (IPF) and SSc and is currently being
studied in a global Phase 3 program in IPF (ISABELA), in addition
to the ongoing NOVESA extension trial.
For more information about ziritaxestat:
www.glpg.com/glpg-1690For information about the studies with
ziritaxestat in systemic sclerosis: www.clinicaltrials.gov
About GalapagosGalapagos
(Euronext & NASDAQ: GLPG) discovers and develops small molecule
medicines with novel modes of action, several of which show
promising patient results and are currently in late-stage
development in multiple diseases. Our pipeline comprises discovery
through Phase 3 programs in inflammation, fibrosis, osteoarthritis
and other indications. Our ambition is to become a leading global
biopharmaceutical company focused on the discovery, development and
commercialization of innovative medicines. More information at
www.glpg.com.
Contacts
Investors:Elizabeth GoodwinVP Investor
Relations +1 781 460 1784
Sofie Van GijselSenior Director Investor Relations+32 485
191415ir@glpg.com
Media:Carmen VroonenGlobal Head Communications
& Public Affairs+32 473 824 874
Anna GibbinsSenior Director Therapeutic Areas Communications+44
7717 801900communications@glpg.com
Forward-looking statements
This release may contain forward-looking
statements, including, among other things, statements regarding
Galapagos' strategic ambitions, the mechanism of action and
potential activity of ziritaxestat the anticipated timing of
clinical trials with ziritaxestat, the progression and results of
such trials, future regulatory submissions and Galapagos'
interactions with regulatory authorities. Galapagos cautions the
reader that forward-looking statements are not guarantees of future
performance. Forward-looking statements involve known and unknown
risks, uncertainties and other factors which might cause the actual
results, financial condition and liquidity, performance or
achievements of Galapagos, or industry results, to be materially
different from any historic or future results, financial conditions
and liquidity, performance or achievements expressed or implied by
such forward-looking statements. In addition, even if Galapagos’
results, performance, financial condition and liquidity, and the
development of the industry in which it operates are consistent
with such forward-looking statements, they may not be predictive of
results or developments in future periods. Among the factors that
may result in differences are that Galapagos’ expectations
regarding its ziritaxestat development program may be incorrect,
the inherent uncertainties associated with competitive
developments, clinical trial and product development activities and
regulatory approval requirements (including that data from
Galapagos’ ongoing clinical research programs may not support
registration or further development of ziritaxestat due to safety,
efficacy or other reasons), Galapagos’ reliance on collaborations
with third parties (including its collaboration partner for
ziritaxestat, Gilead), and estimating the commercial potential of
ziritaxestat. A further list and description of these risks,
uncertainties and other risks can be found in Galapagos’ Securities
and Exchange Commission (SEC) filings and reports, including in
Galapagos’ most recent annual report on Form 20-F filed with the
SEC and other filings and reports filed by Galapagos with the SEC.
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 or that may affect the likelihood that actual
results will differ from those set forth in the forward-looking
statements, unless specifically required by law or regulation.
1 P-value calculated based on least square means
2 Nikpour et al. Curr Opin Rheumatol. 2014
3 GlobalData
4 Europe includes FR, DE, IT, ES, UK only
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