Galapagos completes recruitment of PINTA trial in idiopathic pulmonary fibrosis
January 13 2020 - 1:30AM
Galapagos completes recruitment of PINTA trial in idiopathic
pulmonary fibrosis
Mechelen, Belgium; 13 January 2020, 7.30 CET
– Galapagos NV (Euronext & NASDAQ: GLPG) has completed
recruitment for the PINTA Phase 2 clinical trial with oral GPR84
inhibitor GLPG1205.
PINTA is a randomized, double-blind,
placebo-controlled Phase 2 trial investigating a 100 mg once-daily
oral dose of GLPG1205 in more than 60 patients with idiopathic
pulmonary fibrosis (IPF).
“We are happy with the progress made in our
PINTA trial, with recruitment completed ahead of schedule, and look
forward to learning more about GLPG1205 in IPF,” said Dr. Walid
Abi-Saab, Chief Medical Officer at Galapagos. “We are strongly
committed to the rapid development of our IPF portfolio, including
the worldwide Phase 3 ISABELA program that we are executing with
our collaboration partner Gilead, to address this important unmet
medical need.”
About GLPG1205GLPG1205, fully proprietary
to Galapagos, is a small molecule selectively antagonizing GPR84.
Galapagos identified the GPR84 target using its proprietary target
discovery platform and developed GLPG1205 as an antagonist 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 several Phase 1 trials,
showing favorable findings relating to tolerability and target
engagement in healthy volunteers. GLPG1205 is an investigational
drug and its efficacy and safety have not yet been established.
For information about the studies with GLPG1205:
www.clinicaltrials.gov (NCT03725852)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 250,000 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 current medical
treatment strategy aims to slow the disease progression and improve
the quality of life.
About the PINTA trialPINTA is a
randomized, double-blind, placebo-controlled Phase 2 trial
investigating a 100 mg once-daily oral dose of GLPG1205. The drug
candidate or placebo will be administered for 26 weeks in more than
60 IPF patients. Patients may remain on their local standard of
care as background therapy, whether or not they were previously or
currently are treated with Esbriet®1 (pirfenidone) and Ofev®2
(nintedanib). The 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. Patients in the PINTA trial were recruited in 9 countries in
Europe and the Middle East.
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. Galapagos’ pipeline comprises Phase 3 through to
discovery programs in inflammation, fibrosis, osteoarthritis and
other indications. The Company’s ambition is to become a leading
global biopharmaceutical company focused on the discovery,
development and commercialization of innovative medicines.
Contact
Investors:Elizabeth GoodwinVP Investor Relations +1 781
460 1784
Sofie Van GijselDirector Investor Relations+32 485 19 14
15ir@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 GLPG1205, the anticipated timing, recruitment
or enrollment of clinical trials with GLPG1205, 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 GLPG1205 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 GLPG1205 due to safety, efficacy or other reasons),
Galapagos’ reliance on collaborations with third parties, and
estimating the commercial potential of GLPG1205. 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 Esbriet® (pirfenidone) is an approved drug for IPF, marketed
by Roche/Genentech
2 Ofev® (nintedanib) is an approved drug for IPF, marketed by
Boehringer Ingelheim
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