Galapagos NV (Euronext & NASDAQ: GLPG)
announced today the first dosing in CF patients with the G551D
mutation in the SAPHIRA 1 study.
GLPG1837 is a candidate CFTR potentiator drug in
clinical development for the treatment of Class III mutations in
cystic fibrosis (CF). The full SAPHIRA Phase 2 program will
explore the safety, tolerability and efficacy of GLP1837 in CF
patients with a G551D (SAPHIRA 1) or S1251N (SAPHIRA 2) Class III
mutation. First dosing of the exploratory study SAPHIRA 1
took place this week in Australia.
First dosing in patients with the S1251N
mutation in the SAPHIRA 2 study has started last month.
Topline results from both SAPHIRA 1 and 2 Phase 2 studies are
expected in H2 2016.
"We are very excited about this rapid
recruitment for the SAPHIRA program," said Onno van de Stolpe, CEO
of Galapagos. "We look forward to seeing to what extent our
promising in vitro data translates into clinical results and are
determined to deliver our novel CF compounds to patients as soon as
possible. We aim to start and report a number of clinical
studies with additional compounds in the CF portfolio throughout
2016."
About the SAPHIRA Phase 2 program
SAPHIRA 1, an open-label study of three doses of
GLPG1837 in at least 12 patients with the G551D mutation, was first
dosed in patients this week. 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 February 2016. 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®1 as 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. Both SAPHIRA studies are
recruiting on track with plan.
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 received an additional $20
million in payments from AbbVie 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, three Phase 1, five 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 subsidiary Fidelta, has approximately 440
employees, operating from its Mechelen, Belgium headquarters and
facilities in The Netherlands, France, and Croatia. More
information 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@glpg.com
Forward-looking statements This release may contain
forward-looking statements, including statements regarding the
anticipated timing of the SAPHIRA studies, the further recruitment
of patients for such clinical studies and the potential activity
and clinical utility of potentiator GLPG1837 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 regulation.
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 doses first CF patient with G551D mutation
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