Bli medlem
Bli medlem

Du är här


Galapagos NV: Positive safety and tolerability for novel potentiator GLPG1837

Mechelen, Belgium; 9 October 2015 -
Galapagos NV (Euronext&NASDAQ: GLPG) presents today topline Phase 1 results
with novel potentiator GLPG1837 at the
North American Cystic Fibrosis Conference (NACFC) in Phoenix this week.
GLPG1837 was shown to be safe and well-tolerated and demonstrated favorable
drug-like properties in the study
. GLPG1837 is a candidate drug for the treatment of the Class III mutation in
cystic fibrosis. It is expected that GLPG1837 will be combined with other
Galapagos candidate drugs to create a potential triple combination therapy
for Class II patients, the largest CF-patient group.

Galapagos conducted a randomized, double-blind, placebo-controlled study over
a range of single and multiple doses of GLPG1837 in healthy human volunteers
in Belgium. In the single ascending dose (SAD) part of the study subjects
were exposed to single oral doses of 30 to 2000 mg. In the multiple
ascending dose (MAD) part of the study, GLPG1837 was given orally at doses of
125 to 800 mg twice daily for a period of 14 days.

On safety, GLPG1837 up to a single dose of 2000 mg and up to 800 mg twice
daily for 14 days was generally safe and well tolerated in this study. There
were no adverse effects observed on ECG, vital signs, or on laboratory
parameters. Treatment-emergent adverse events were rare, with the most
common adverse events reported being headache and tiredness.

The pharmacokinetics of GLPG1837 also proved favorable in this study. Rapid
absorption occurred, with a mean apparent elimination half-life of 6-15
hours. The bioavailability of GLPG1837 was improved with food. Steady state
was attained within the second dosing, with no accumulation.

The company believes the results from this Phase 1 study support rapid
progression into a Phase 2 study in Class III mutation patients, which is
expected to commence before year end 2015.

Friday, 9 October: Poster 258, 7.30 AM - 8.45 AM SMT
"Safety, tolerability and pharmacokinetics of a novel CFTR Potentiator
GLPG1837 in healthy volunteers"
This poster will be made available on the Galapagos website,,
shortly following the presentation session on 9 October.

The North American Cystic Fibrosis Conference is sponsored by the Cystic

About cystic fibrosis (CF)

CF is a rare, life-threatening, genetic disease that affects approximately
80,000 patients worldwide and approximately 30,000 patients in the United
States. CF is a chronic disease that affects the lungs and digestive system.
CF patients, with significantly impaired quality of life, have an average
lifespan approximately 50% shorter than the population average, with the
median age of death at 27. There currently is no cure for CF. CF patients
require lifelong treatment with multiple daily medications, frequent
hospitalizations and ultimately lung transplant, which is life-extending but
not curative. CF is caused by a mutation in the gene for the CFTR protein,
which results in abnormal transport of chloride across cell membranes.
Transport of chloride is required for effective hydration of epithelial
surfaces in many organs of the body. Normal CFTR channel moves chloride ions
to outside of the cell. Mutant CFTR channel does not move chloride ions,
causing sticky mucous to build up on the outside of the cell. CFTR
dysfunction results in dehydration of dependent epithelial surfaces, leading
to damage of the affected tissues and subsequent disease, such as lung
disease, malabsorption in the intestinal tract and pancreatic insufficiency.

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, with a pipeline comprising three Phase 2 programs, two
Phase 1 trials, five pre-clinical studies, and 20 discovery small-molecule
and antibody programs in cystic fibrosis, inflammation, and other
indications. Filgotinib is an orally-available, selective inhibitor of JAK1
for the treatment of rheumatoid arthritis and potentially other inflammatory
diseases. Galapagos has reported good activity and a favorable safety profile
in both the DARWIN 1 and 2 trials in RA. Galapagos is preparing to enter
Phase 3 studies in RA and to report Phase 2 topline results with filgotinib
in Phase 2 in Crohn's disease. In the field of cystic fibrosis, AbbVie and
Galapagos signed a collaboration agreement to develop and commercialize
molecules that address mutations in the CFTR gene. Potentiator GLPG1837 has
completed a Phase 1 trial, and corrector GLPG2222 is expected to enter Phase
1 by end 2015. GLPG1205, a first-in-class inhibitor of GPR84 and fully-owned
by Galapagos, will report topline results in Q4 2015 from a Phase 2
proof-of-concept trial in ulcerative colitis patients. GLPG1690, a fully
proprietary, first-in-class inhibitor of autotaxin, has shown favorable
safety in a Phase 1 trial and is expected to enter Phase 2 in idiopathic
pulmonary fibrosis. The Galapagos Group, including fee-for-service
subsidiary Fidelta, has approximately 400 employees, operating from its
Mechelen, Belgium headquarters and facilities in The Netherlands, France, and
Croatia. More info at


Galapagos NV

Elizabeth Goodwin, VP IR&Corporate Communications
Cell: +1 781 460 1784

Media inquiries:
Evelyn Fox, Director Communications
Tel: +31 6 53 591 999

Galapagos forward-looking statements

This release may contain forward-looking statements, including statements
regarding the safety, tolerability and activity of GLPG1837 and the potential
timing of future clinical trials. Galapagos cautions the reader that
forward-looking statements are not guarantees of future performance. In
particular it should be noted that the positive results of the Phase 1 trial
of GLPG1837 may not be indicative of future results, either on a stand-alone
basis or as part of a combination therapy. 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, clinical trial and product development activities
and regulatory approval requirements (including that data from Galapagos'
ongoing clinical research programs in cystic fibrosis may not support
registration or further development of its potentiators and/or correctors due
to safety, efficacy or other reasons), Galapagos' reliance on collaborations
with third parties (including its collaboration partner, AbbVie, who may not
devote sufficient resources to the development and commercialization of the
cystic fibrosis programs), and estimating the commercial potential of our
product candidates. A further list and description of these risks,
uncertainties and other risks can be found in the company's Securities and
Exchange Commission filing and reports, including in the company's prospectus
filed with the SEC on May 14, 2015 and future filings and reports filed by
the company with the Secuirities and Exchange Commission. 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.


This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX 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


Författare Hugin

Tala om vad ni tycker

Tala om vad ni tycker

Ni är just nu inne på en betaversion av nya aktiespararna. Lämna gärna feedback på vad ni tycker i formuläret nedan.