Galapagos reports initiation of FALCON clinical trial in cystic fibrosis
April 24 2018 - 2:46AM
- Our first triple combination investigational therapy for CF
patients
- combination of '2451+'2222+'2737
- multiple centers in Europe
- topline results expected Q3 2018
Mechelen,
Belgium; 24 April 2018; 08.45 AM CET - Galapagos NV
(Euronext & NASDAQ: GLPG) announces initiation of its first
clinical trial with an investigational triple combination therapy
in cystic fibrosis patients.
The aim of the FALCON trial is to evaluate the
efficacy, safety, tolerability, and pharmacokinetics of a novel
triple combination in up to 24 CF patients. The open label trial is
being conducted in multiple centers, initially in the United
Kingdom with expansion expected to other European countries.
The FALCON study will comprise two parts. Part
one will entail treatment of 8 patients for two weeks with a fixed
dose dual combination of potentiator GLPG2451 and C1 corrector
GLPG2222 in homozygous F508del patients. This will be followed by
two weeks' treatment with '2451, '2222, and C2 corrector GLPG2737.
Part two will entail treatment for two weeks with a higher dose
dual combination of '2451 and '2222 in separate 8 patient cohorts
of homozygous F508del patients and heterozygous F508del patients
with a minimal function mutation on the other allele. This will be
followed by two weeks' treatment with '2451, '2222, and '2737.
Efficacy will be measured by changes in sweat chloride and percent
predicted forced expiratory volume during the first second
(ppFEV1%). Topline results from treatment in part one of FALCON are
expected to be disclosed Q3 2018.
"Today marks a key milestone in our CF program.
Since 2005, it has been our ambition to develop a disease-modifying
therapy for CF. Now we are evaluating a first triple combination in
CF patients, with the next triple combination coming up rapidly
behind it," said Dr. Piet Wigerinck, CSO of Galapagos. "These steps
bring us closer to our goal of offering patients, doctors, and
payers more choice in their CF therapies."
GLPG2451, GLPG2222, GLPG2737 (and combinations
thereof) are investigational therapies; their safety and efficacy
have not been established.
About GalapagosGalapagos (Euronext &
NASDAQ: GLPG) is a clinical-stage biotechnology company specialized
in the discovery and development of small molecule medicines with
novel modes of action. Galapagos' pipeline comprises Phase 3
through to discovery programs in cystic fibrosis, inflammation,
fibrosis, osteoarthritis and other indications. Our target
discovery platform has delivered three novel mechanisms showing
promising patient results in, respectively, inflammatory diseases,
idiopathic pulmonary fibrosis and atopic dermatitis. 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 600
employees, operating from its Mechelen, Belgium headquarters and
facilities in the Netherlands, France, Switzerland, the US and
Croatia. More information at www.glpg.com.
Contacts
Investors:Elizabeth GoodwinVP IR & Corporate
Communications+1 781 460 1784
Paul van der HorstDirector IR & Business Development +31 71
750 6707ir@glpg.com
Media:Evelyn FoxDirector Communications +31 6 53 591 999
communications@glpg.com
Forward-looking statementsThis release may contain
forward-looking statements, including statements regarding
Galapagos' strategic ambitions, the composition of a potential
triple combination therapy for CF; the potential activity of
GLPG2451, GLPG2222, GLPG2737 and/or of combinations thereof in CF;
the anticipated timing of clinical trials with, and plans related
to, the CF portfolio of product candidates; the timing, progression
and/or results of such trials and plans. 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 the ongoing and planned clinical research
programs in CF may not support registration or further development
of a potential triple combination or any of Galapagos' potentiators
or correctors (alone or in combination) due to safety, efficacy or
other reasons), Galapagos' reliance on collaborations with third
parties (including its collaboration partner for CF, AbbVie), and
estimating the commercial potential of Galapagos' CF portfolio. 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 subsequent
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.
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