Paris (France) and Mechelen (Belgium), 26
June 2018, 22.01 CET - Servier, an independent international
pharmaceutical company, and Galapagos NV (Euronext &
NASDAQ: GLPG) announce the start of a global Phase 2 trial with
S201086/GLPG1972 in knee osteoarthritis patients: ROCCELLA.
Galapagos will be eligible to receive a €9 million milestone
payment upon first dosing of a patient in ROCCELLA.
Servier and Galapagos have submitted and will
further submit clinical trial applications in a number of countries
in North and South America, Europe and Asia. The study will now be
initiated in the US and Hungary with other countries expected to
follow, pending the respective regulatory approvals. ROCCELLA will
be a multiregional, randomized, double-blind, placebo-controlled,
dose ranging trial evaluating the efficacy and safety of three
different once-daily doses of S201086/GLPG1972 in patients with
knee osteoarthritis (OA). ROCCELLA is planned to recruit
approximately 850 patients in up to 15 countries. Galapagos will be
responsible for ROCCELLA in the United States, where 300 patients
are targeted to be recruited. Servier will run the trial in all
other countries.
The primary objective of ROCCELLA is to
demonstrate the efficacy of at least one dose of S201086/GLPG1972
compared to placebo in reducing cartilage loss after 52 weeks of
treatment. Cartilage thickness will be measured using quantitative
magnetic resonance imaging of the central medial tibiofemoral
compartment of the target knee. Secondary objectives include safety
and tolerability, several additional measures of structural
progression, changes in bone area, pain, function, stiffness, and
patient global assessment.
S201086/GLPG1972 is a disease-modifying
osteoarthritis drug (DMOAD) candidate targeting efficiently a
cartilage degrading enzyme called ADAMTS-5, as confirmed in two
animal models. A Phase 1 trial in healthy volunteers met all its
safety and pharmacokinetic targets and also demonstrated that
S201086/GLPG1972 reduced by approximately 50% within two weeks the
blood level of ARGS neoepitope, a biomarker for cartilage
breakdown. In a more recent Phase 1b trial in OA patients in the
United States, similar findings were seen over a four-week period.
Specifically, S201086/GLPG1972 was well tolerated and it reduced,
in a dose-dependent manner, the ARGS neoepitope blood levels by up
to 50%.
"People living with osteoarthritis of the knee
experience a major loss of quality of life, mainly because of the
ever-present pain and increasing loss of mobility. Any therapeutic
innovation that can prevent or slow down the underlying cartilage
loss will thus address a huge unmet patient need for the many
people affected by osteoarthritis in our aging populations", said
Lode Dewulf, Chief Patient Officer at Servier.
"The robust design of ROCCELLA should provide
deep insights into the disease-modifying potential and the safety
and tolerability of this novel therapeutic candidate in patients
with knee OA. We have seen clear target engagement in OA patients;
now we should be able to answer how this translates to protection
against cartilage breakdown," said Dr. Walid Abi-Saab, Chief
Medical Officer of Galapagos. "We look forward to working with our
collaboration partner Servier to execute ROCCELLA as rapidly as
possible, with the goal of providing OA patients with a first
disease-modifying drug."
"Due to its unique mechanism of action based on
the inhibition of cartilage degradation, S201086/GLPG1972 has the
potential to help patients with osteoarthritis by altering the
course of their disease. We look forward to launch the ROCCELLA
Phase 2 trial as a global effort conducted jointly by Servier and
Galapagos to fulfill the needs of patients suffering from
osteoarthritis", said Philippe Moingeon Head of Center for
Therapeutic Innovation at Servier.
OA is a highly prevalent and disabling
pathology. So far, no treatment is available to counteract disease
progression, and patients are left with only symptomatic
treatments. As a result, OA represents an important unmet medical
need. Galapagos developed investigational molecule S201086/GLPG1972
with the potential of becoming a first-in-class DMOAD as part of a
collaboration with Servier signed in 2010. Galapagos has full U.S.
commercial rights to S201086/GLPG1972. Under the terms of the
agreement, Galapagos is also eligible to receive development,
regulatory and other milestone payments plus royalties upon
commercialization outside the United States.
S201086/GLPG1972 is an investigational drug
candidate and its safety and efficacy have not yet been
established.
About Servier Servier is an international
pharmaceutical company governed by a non-profit foundation, with
its headquarters in France (Suresnes). With a strong international
presence in 148 countries and a turnover of 4.152 billion euros in
2017, Servier employs 21,600 people worldwide. Entirely
independent, the Group reinvests 25% of its turnover (excluding
generic drugs) in research and development and uses all its profits
for development. Corporate growth is driven by Servier's constant
search for innovation in five areas of excellence: cardiovascular,
immune-inflammatory and neuropsychiatric diseases, cancers and
diabetes, as well as by its activities in high-quality generic
drugs. Servier also offers eHealth solutions beyond drug
development.
More information: www.servier.com
Servier press contacts :
Sonia Marques
: media@servier.com - Tel. : +33 (0)1 55 72 40 21 / + 33 (0) 7
84 28 76 13Karine
Bousseau :
media@servier.com - Tel. : +33 (0)1 55 72 60 37 About
GalapagosGalapagos (Euronext & NASDAQ: GLPG) is a
clinical-stage biotechnology company specialized in the discovery
and development of small molecule medicines with novel modes of
action. Galapagos' pipeline comprises Phase 3 through to discovery
programs in cystic fibrosis, inflammation, fibrosis, osteoarthritis
and other indications. Our target discovery platform has delivered
three novel mechanisms showing promising patient results in,
respectively, inflammatory diseases, idiopathic pulmonary fibrosis
and atopic dermatitis. Galapagos is focused on the development and
commercialization of novel medicines that will improve people's
lives. The Galapagos group, including fee-for-service subsidiary
Fidelta, has approximately 640 employees, operating from its
Mechelen, Belgium headquarters and facilities in the Netherlands,
France, Switzerland, the US and Croatia. More information at
www.glpg.com.
Contacts Galapagos:
Investors:Elizabeth GoodwinVP IR & Corporate
Communications +1 781 460 1784
Paul van der HorstDirector IR & Business Development +31 71
750 6707ir@glpg.com
Media:Evelyn FoxDirector Communications +31 6 53 591 999
communications@glpg.com
Galapagos forward-looking statements This
release may contain forward-looking statements, including, among
other things, statements regarding the mechanism of action and
profile of, and timing and results of clinical trials with, and
potential commercialization of, GLPG1972. 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 GLPG1972 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 the ongoing
clinical research programs may not support registration or further
development of GLPG1972 due to safety, efficacy or other reasons),
Galapagos' reliance on collaborations with third parties (including
its collaboration partner for OA Servier), and estimating the
commercial potential of Galapagos' product candidates. 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.
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