Mechelen,
Belgium; 9 July 2018; 7.30 CET - Galapagos NV (Euronext &
NASDAQ: GLPG) announces the PINTA Phase 2 trial design with its
GPR84 inhibitor GLPG1205 in patients with idiopathic pulmonary
fibrosis (IPF).
PINTA is a randomized,
double-blind, placebo-controlled trial investigating a 100 mg
once-daily oral dose of GLPG1205. The drug candidate or placebo
will be administered for 26 weeks in up to 60 IPF patients.
Patients may remain on their local standard of care as background
therapy. Primary objective of the trial is to assess the change
from baseline in Forced Vital Capacity (FVC in mL) over 26 weeks
compared to placebo. Secondary measures include safety,
tolerability, pharmacokinetics and pharmacodynamics, time to major
events, changes in functional exercise capacity, and quality of
life. IPF diagnosis will be confirmed by central reading.
Recruitment for PINTA is planned in 10 countries in Europe, North
Africa, and the Middle East. First dosing of an IPF patient is
expected in the second half of 2018.
GLPG1205 is a GPR84 inhibitor
discovered by Galapagos and fully proprietary to Galapagos.
GLPG1205 showed a reduction in signs and symptoms in IPF animal
models and has shown favorable tolerability in healthy volunteers
and ulcerative colitis patients in previous trials. Galapagos
currently has three drug candidates with distinct mechanisms of
action in its fully proprietary portfolio aimed at building an IPF
franchise: GLPG1690 in the ISABELA Phase 3 program, GLPG1205 in
PINTA Phase 2, and GLPG3499, currently in pre-clinical
development.
"GLPG1205 has shown signs of good
activity in relevant animal models, and GPR84 has already been
validated as a mechanism in combination with nintedanib[1] in IPF,"
added Dr. Piet Wigerinck, Chief Scientific Officer of Galapagos.
"We have a well-designed trial with PINTA for '1205 that we
anticipate will give us new insights into the potential value of
GPR84 inhibition as a mechanism to treat this highly fatal
disease."
About
GLPG1205
GLPG1205 is a small molecule selectively inhibiting GPR84,
which is fully proprietary to Galapagos. Galapagos identified the
GPR84 target using its proprietary target discovery platform and
developed molecule GLPG1205 as an inhibitor of this target.
GLPG1205 showed promising results in relevant pre-clinical models
for IPF, and there is growing evidence in scientific literature and
in clinical research that GPR84 plays a role in this disease.
GLPG1205 successfully completed a Phase 1 trial in 2013, showing
favorable findings relating to safety and tolerability, and target
engagement in healthy volunteers. GLPG1205 showed good tolerability
but no activity in ulcerative colitis patients in 2016. GLPG1205 is
an investigational drug and its efficacy and safety have not been
established.
For information about the studies
with GLPG1205: www.clinicaltrials.gov (posting expected in Q3
'18)
For more information about GLPG1205: www.glpg.com/ipf
About IPF
IPF is a chronic, relentlessly progressive fibrotic disorder of the
lungs that typically affects adults over the age of 40. There are
approximately 200,000 patients with IPF in the U.S. and Europe. As
such, IPF is considered a rare disease. The clinical prognosis of
patients with IPF is poor as the median survival at diagnosis is 2
to 4 years. Currently, no medical therapies have been found to cure
IPF. The medical treatment strategy aims to slow the disease
progression and improve the quality of life.
Regulatory agencies have approved
Esbriet®[2]
(pirfenidone) and Ofev® (nintedanib)
for the treatment of IPF. Both pirfenidone and nintedanib have been
shown to slow the rate of lung function decline in IPF and are
gaining ground as the standard of care worldwide. These regulatory
approvals represent a major breakthrough for IPF patients; yet
neither drug improves lung function, and the disease continues to
progress in the majority of patients despite treatment. Moreover,
the adverse effects associated with these therapies include
diarrhea, liver function test abnormalities with nintedanib, nausea
and rash with pirfenidone. Therefore, there is still a large unmet
medical need as IPF remains a major cause of morbidity and
mortality.
About Galapagos
Galapagos (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.
Contact
Investors:
Elizabeth Goodwin
VP IR & Corporate Communications
+1 781 460 1784
Paul van der Horst
Director IR & Business Development
+31 71 750 6707
ir@glpg.com
Media:
Evelyn Fox
Director Communications
+31 6 53 591 999
communications@glpg.com
Forward-looking
statements
This release may contain forward-looking
statements, including statements regarding Galapagos' strategic
ambitions, the potential activity of GLPG1205, the anticipated
timing of future clinical studies with GLPG1205, the progression
and results of such studies, and Galapagos' interactions with
regulatory authorities, and statements regarding the current
landscape of IPF treatments, including Esbriet® (pirfenidone) and Ofev® (nintedanib), and the
unmet medical need for IPF treatments. 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 the inherent uncertainties associated
with competitive developments, (including with respect to
Esbriet® (pirfenidone)
and Ofev®
(nintedanib)), clinical trial and product development activities
and regulatory approval requirements (including that data from the
ongoing and planned clinical research programs may not support
registration or further development of GLPG1205 due to safety,
efficacy or other reasons), Galapagos' reliance on collaborations
with third parties, 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 subsequent
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]
Ofev® (nintedanib)
is indicated for the treatment of IPF by Boehringer Ingelheim.
[2]
Esbriet® (pirfenidone)
is indicated for the treatment of IPF by Roche/Genentech.
PINTA
This
announcement is distributed by Nasdaq Corporate Solutions on behalf
of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: Galapagos NV via Globenewswire
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