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Galapagos NV: Galapagos starts SAPHIRA Phase 2 study with GLPG1837 in cystic fibrosis patients

Topline results in Class III mutation patients expected Q4 2016

Mechelen, Belgium; 16 February 2016 - Galapagos NV
(Euronext&NASDAQ: GLPG)
announced today the first dosing in its Phase 2 exploratory program of
GLPG1837 in patients with cystic fibrosis (CF).

GLPG1837 is a candidate CFTR potentiator drug in clinical development for the
treatment of Class III mutations in cystic fibrosis. The SAPHIRA Phase 2
program will explore the safety, tolerability and efficacy properties of
GLP1837 in CF patients with a G551D (SAPHIRA 1) or S1251N (SAPHIRA 2) Class
III mutation. Topline results from the SAPHIRA Phase 2 program are expected
in Q4 2016.

"Today's announcement is a landmark achievement in our CF program, with the
first CF patient being treated with a Galapagos potentiator," said Onno van
de Stolpe, CEO of Galapagos. "Recruitment for the SAPHIRA program is rapid,
and we look forward to seeing to what extent our promisingin vitro
data translates into clinical results. We aim to start and report a number of
clinical studies with additional compounds in the CF portfolio throughout

Details of the SAPHIRA Phase 2 program

SAPHIRA 2, an open-label study of two doses of GLPG1837 in at least six CF
patients with the S1251N mutation, was first dosed in a patient last week.
SAPHIRA 1, an open-label study of three doses of GLPG1837 in at least 12
patients with the G551D mutation, is expected to begin dosing soon. The
SAPHIRA Phase 2 program will explore the safety, tolerability, efficacy, and
medicine-like properties of GLPG1837 in patients in six EU countries and
Australia. Primary objectives are to evaluate the safety and tolerability;
secondary objectives are to assess changes in sweat chloride from baseline as
the biomarker of cystic fibrosis transmembrane conductance regulator (CFTR)
ion channel function and to explore the changes in pulmonary function (forced
expiratory volume in 1 second [FEV1]) from baseline. Both studies will
include subjects treated with Kalydeco®1as well as those who are naïve to
this drug. In each study, different doses of GLPG1837 tablets will be
administered twice daily for a total duration of four weeks.

About the Galapagos - AbbVie collaboration in cystic fibrosis

In September 2013 Galapagos and AbbVie, a global biopharmaceutical company,
entered into a global collaboration agreement focused on the discovery and
worldwide development and commercialization of potentiator and corrector
molecules in a potential triple combination therapy for the treatment of CF.
Under the terms of the agreement, AbbVie made an upfront payment of $45
million to Galapagos. Upon successful completion by Galapagos of clinical
development through to completion of Phase 2, AbbVie will be responsible for
Phase 3, with financial contribution by Galapagos. Galapagos has earned $20
million in milestone payments to date and is eligible to receive up to $340
million in total additional payments for developmental and regulatory
milestones, sales milestones upon the achievement of minimum annual net sales
thresholds and additional tiered royalty payments on net sales, ranging from
mid-teens to 20%.

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 40. 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. Our pipeline comprises three Phase 2, two Phase 1,
four pre-clinical, and 20 discovery studies in cystic fibrosis, inflammation,
fibrosis, osteoarthritis and other indications. We have discovered and
developed filgotinib: in collaboration with Gilead we aim to bring this
JAK1-selective inhibitor for inflammatory indications to patients all over
the world.
Galapagos is focused on the development and commercialization of novel
medicines that will improve people's lives. The Galapagos group, including
fee-for-service subsidiaryFidelta, has approximately 400 employees, operating
from its Mechelen, Belgium headquarters and facilities in The Netherlands,
France, and Croatia. More information at


Galapagos NV

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

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

Galapagos forward-looking statements

This release may contain forward-looking statements, including statements
regarding the anticipated timing of clinical studies, the potential activity
and clinical utility of potentiator
and of a potential triple combination including this compound for cystic
fibrosis. 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, 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 GLPG1837 to safety, efficacy or other
reasons), Galapagos' reliance on collaborations with third parties (including
the performance by AbbVie under the Galapagos-AbbVie Collaboration
Agreement), 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
Securities and Exchange Commission on May 14, 2015 and subsequent filings and
reports filed by the company with the Securities 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

1 Kalydeco®is a prescription medicine sold by Vertex Pharmaceuticals, used for the treatment of cystic fibrosis (CF) in patients age 6 years and older who have several specific Class III mutations in the CFTR protein including G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, or R117H.

Galapagos starts SAPHIRA Phase 2 study with GLPG1837 in CF-patients


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


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