Galapagos reports initiation of global ROCCELLA Phase 2 clinical trial with GLPG1972/S201086 in osteoarthritis patients
September 24 2018 - 1:31AM
Mechelen, Belgium, September 24 2018, 07.30
CET - Galapagos NV (Euronext & NASDAQ: GLPG) reports
first dosing in the global ROCCELLA Phase 2 trial with
GLPG1972/S201086 in knee osteoarthritis patients. Galapagos
receives a €9 million milestone payment from its collaboration
partner Servier for this achievement.
ROCCELLA is a multiregional, randomized,
double-blind, placebo-controlled, dose ranging trial evaluating the
efficacy and safety of three different once-daily doses of
GLPG1972/S201086 in patients with knee osteoarthritis (OA).
ROCCELLA is planned to recruit approximately 850 patients in
countries in Europe, Asia, North America and South America.
Galapagos is 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 GLPG1972/S201086
compared to placebo in reducing cartilage loss after 52 weeks of
treatment. This cartilage loss will be measured precisely by
magnetic resonance imaging (MRI). Secondary objectives include
safety and tolerability, several additional measures of structural
progression, improvement in pain, function, stiffness, and patient
global assessment.
GLPG1972/S201086 is a disease-modifying
osteoarthritis drug (DMOAD) candidate that, in two animal models,
has been shown to efficiently target a cartilage degrading enzyme
called ADAMTS-5. A Phase 1 trial in healthy volunteers met all of
its safety and pharmacokinetic targets and also demonstrated that
GLPG1972/S201086 reduced the blood level of the ARGS neoepitope by
approximately 50% within two weeks. ARGS neoepitope is a biomarker
for ADAMTS-5 activity and, as such, serves as a reflection of
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, GLPG1972/S201086 was well tolerated and
reduced ARGS neoepitope blood levels by up to 50%.
OA is a highly prevalent and disabling
pathology. There are no treatments available today that counteract
disease progression. Patients are left with only symptomatic
treatments. As a result, OA represents an important unmet medical
need. Galapagos developed investigational molecule GLPG1972/S201086
with the potential of becoming a first-in-class DMOAD as part of a
collaboration with Servier that began in 2010. Galapagos has full
U.S. commercial rights to GLPG1972/S201086 and is eligible to
receive development, regulatory and other milestone payments plus
royalties from Servier upon commercialization outside the United
States.
GLPG1972/S201086 is an investigational drug
candidate and its safety and efficacy have not yet been
established. More information on the clinical study can be found at
www.clinicaltrials.gov (NCT03595618).
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 675
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
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, 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.
- ROCCELLA Phase1.pdf
- ROCCELLA Phase1.pdf
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