Galapagos starts Phase 1 study with potentiator GLPG2451 for CF
May 09 2016 - 4:09PM
Galapagos NV (Euronext & NASDAQ: GLPG) announces the start
of a Phase 1 study with potentiator GLPG2451 for cystic fibrosis
(CF). Following GLPG1837, GLPG2451 is the second potentiator
compound in Galapagos' extended CF-portfolio to enter clinical
trials.
Galapagos is conducting a randomized,
double-blind, placebo-controlled study over a range of doses of
GLPG2451 in healthy volunteers in Belgium and the Netherlands and
expects topline results in Q4 2016. The start of this Phase 1
study triggers a $10 million milestone payment from AbbVie under
the recently expanded global collaboration agreement.
Galapagos and AbbVie aim to develop a triple
CFTR combination therapy to address 90% of patients with CF.
In order to bring a more effective therapy to patients, the
companies have developed multiple candidates and backups for each
of the three components of a potential triple combination.
GLPG2451 is the second potentiator and the third compound in
the portfolio to enter the clinic.
Potentiator series
GLPG2451 is the second potentiator candidate to
enter clincial evaluation. Galapagos is recruiting for the
SAPHIRA exploratory Phase 2 program with the first potentiator,
GLPG1837, in patients with G551D and S1251N mutations.
Results from the SAPHIRA program are expected in the second half of
2016.
Early binding (C1) corrector series
Dosing to humans of GLPG2222, the first early
binding corrector in Galapagos' portfolio, started in January
2016. Galapagos is conducting a randomized, double-blind,
placebo-controlled study over a range of doses of GLPG2222 in
healthy volunteers in Belgium and expects topline results in Q2
2016. Earlier this year, Galapagos announced selection of
preclinical candidate GLPG2851, an additional early binding
corrector.
Late binding (C2) corrector series
Galapagos announced selection of the first late
binding corrector GLPG2665 last year and selection of an
additional late binding corrector in the same series, GLPG2737,
this year. Galapagos expects to enter Phase 1 with one of
these late binding correctors in healthy volunteers in the second
half of 2016.
More information about the Galapagos-AbbVie collaboration in
cystic fibrosis: www.glpg.com/alliances
More information about cystic fibrosis:
www.glpg.com/rd-cystic-fibrosis
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
maturing pipeline comprises Phase 2, Phase 1, pre-clinical and
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 400
employees, operating from its Mechelen, Belgium headquarters and
facilities in The Netherlands, France, and Croatia. More
information at www.glpg.com.
Contacts
Investors: |
Media: |
Elizabeth Goodwin |
Evelyn
Fox |
VP IR
& Corporate Communications +1 781 460 1784 |
Director
Communications +31 6 53 591 999 communications@glpg.com
|
Paul van
der Horst Director IR & Business Development +31 6 53 725
199 |
|
ir@glpg.com |
|
Forward-looking statements
This release may contain forward-looking statements, including
statements regarding any anticipated milestone payment, the
anticipated timing of clinical studies, the potential activity of
GLPG1837, GLPG2222, GLPG2451, GLPG2665, GLPG 2737, GLPG2851 and of
a potential triple combination including any of these compounds 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 its correctors and potentiators due 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 its product
candidates. A further list and description of these risks,
uncertainties and other risks can be found in Galapagos' Securities
and Exchange Commission (SEC) filing 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.
GLPG starts Phase 1 study with GLPG2451 for CF
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