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 GLPG1205GLPG1205 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 IPFIPF 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 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.
ContactInvestors: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
Forward-looking statementsThis 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.
Galapagos NV (NASDAQ:GLPG)
Historical Stock Chart
From Aug 2024 to Sep 2024
Galapagos NV (NASDAQ:GLPG)
Historical Stock Chart
From Sep 2023 to Sep 2024