Galapagos completes recruitment of NOVESA trial in systemic sclerosis
December 05 2019 - 4:01PM
Mechelen, Belgium; 5 December 2019,
22.01 CET – Galapagos NV (Euronext & NASDAQ: GLPG) has
completed recruitment for the NOVESA Phase 2 clinical trial with
GLPG1690.
NOVESA is a double-blind, placebo-controlled
Phase 2a trial evaluating the efficacy, safety and PK/PD of
GLPG1690 in patients with systemic sclerosis (SSc), an autoimmune
disease involving multiorgan fibrosis which has one of the highest
mortality rates among rheumatic diseases1. NOVESA recruited 33
patients with diffuse cutaneous systemic sclerosis (dcSSc). One of
the most visible manifestations is hardening of the skin. In dcSSc,
the skin thickening is more widespread; these patients have a
higher risk of developing fibrosis of multiple internal organs,
including the lung. There are no approved drugs for this disease.
SSc affects approximately 124,000 patients2 in the US and Europe3,
with a predominance of female patients (>80%).
The primary endpoint of NOVESA is the modified
Rodnan Skin Score (mRSS) at 24 weeks. mRSS measures the skin
thickness as a surrogate measure of disease severity and mortality
in those with dcSSc. An increase in skin thickness is associated
with involvement of internal organs and increased mortality4.
Secondary and exploratory parameters include FVC5, HRCT6, safety
and tolerability, quality of life as measured by QoL-Q (SHAQ)7, and
CRISS8, a SSc disease composite score. Topline results from the
NOVESA trial are expected in the second half of 2020. Patients
completing the NOVESA study are offered the opportunity to roll
over to a long-term extension trial.
“We are excited by the rapid enrollment
into NOVESA and look forward to learning the results of GLPG1690’s
efficacy and safety in patients with SSc. We consider SSc as an
important and complementary indication to idiopathic pulmonary
fibrosis, where a global Phase 3 program is underway,” said
Dr Walid Abi-Saab, Chief Medical Officer of Galapagos. “Thanks to
the broad mechanism of action of ‘1690, which we believe is both
anti-inflammatory and anti-fibrotic, this compound has the
potential to address the important unmet medical need in SSc.”
About GLPG1690GLPG1690 is a
small molecule, selective autotaxin inhibitor that was inlicensed
by Gilead Sciences, Inc. as part of the global R&D
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 GLPG1690 as an inhibitor
of this target. GLPG1690 is currently being studied in a global
Phase 3 program in idiopathic pulmonary fibrosis (ISABELA) as well
as in the NOVESA trial.
GLPG1690 is an investigational drug and its
efficacy and safety have not been established by any regulatory
agency.
For more information about GLPG1690:
www.glpg.com/glpg-1690For information about the studies with
GLPG1690 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 Phase 3
through to discovery 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 GijselDirector Investor Relationsir@glpg.com
Media:Carmen VroonenSenior Director
Communications & Public Affairs+32 473 824 874
Evelyn FoxDirector Communications +31 6 53 591 999
communications@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 GLPG1690, the anticipated timing of clinical
trials with GLPG1690, 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 GLPG1690 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 GLPG1690 due to safety, efficacy or other reasons),
Galapagos’ reliance on collaborations with third parties (including
its collaboration partner for GLPG1690, Gilead), and estimating the
commercial potential of GLPG1690. 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 Nikpour et al. Curr Opin Rheumatol. 2014
2 GlobalData
3 Europe includes FR,DE,IT,ES,UK only
4 LeRoy et al. J Rheumatol. 2001; Dobrota et al. Annals Rheum
Dis. 2016
5 Forced Vital Capacity
6 High-resolution computed tomography
7 Scleroderma Health Assessment Questionnaire – Disability
Index
8 Combined Response Index of diffuse cutaneous Systemic
Sclerosis
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