Positive safety and tolerability for novel potentiator GLPG1837
(Thomson Reuters ONE) -
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, www.glpg.com,
shortly following the presentation session on 9 October.
The North American Cystic Fibrosis Conference is sponsored by the Cystic
Fibrosis Foundation: www.cff.org
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 www.glpg.com
CONTACT
Galapagos NV
Investors:
Elizabeth Goodwin, VP IR & Corporate Communications
Cell: +1 781 460 1784
Media inquiries:
Evelyn Fox, Director Communications
Tel: +31 6 53 591 999
ir(at)glpg.com
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 GlobeNewswire on behalf of
GlobeNewswire clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Galapagos NV via GlobeNewswire
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