First patient dosed with GLPG3667 in psoriasis patient Phase 1b trial
November 09 2020 - 4:01PM
First patient dosed with GLPG3667 in psoriasis patient Phase 1b
trial
Mechelen, Belgium; 9 November 2020, 22.01 CET –
Galapagos NV (Euronext & NASDAQ: GLPG) announces dosing of the
first psoriasis patient in the Phase 1b trial with
GLPG3667.
GLPG3667 is a proprietary compound with an
undisclosed mechanism of action in development for inflammatory and
autoimmune indications. Based on an initial clinical study in
healthy volunteers, GLPG3667 has met the criteria to be further
studied in patients.
This Phase 1b trial is a randomized,
double-blind, placebo-controlled, multicenter study to evaluate the
safety, tolerability, efficacy, pharmacokinetics, and
pharmacodynamics of GLPG3667. A daily oral administration of
GLPG3667 at two different dose levels or a placebo will be
investigated for 4 weeks in 30 patients with moderate to severe
plaque psoriasis. The primary endpoint will be the change from
baseline in Psoriasis Area Severity Index (PASI) score at 4 weeks.
The first patient was dosed today. Recruitment will be based in
Europe.
Pending successful completion of the Phase 1b
study in psoriasis, we anticipate evaluating GLPG3667 in dose range
finding Phase 2 studies in psoriatic arthritis and ulcerative
colitis in the second half of 2021.
“We continue to press forward with several
mechanisms of action in inflammation as part of our strategy to
bring improved therapies to patients. We look forward to applying
our extensive clinical experience in inflammation to this
additional approach with GLPG3667. The study in psoriasis and the
biomarker information collected should pave the way for trials in
psoriatic arthritis and other indications,” said Dr. Piet
Wigerinck, Chief Scientific Officer of Galapagos.
GLPG3667 is an investigational drug and not
approved by any regulatory authority. Its efficacy and safety have
not been established.
About our early inflammation
pipelineGalapagos continues to innovate in the
inflammation space, with multiple, distinct mechanism of action
approaches to bringing new therapy options to patients. GLPG3667 is
an oral small molecule with undisclosed mechanism of action
currently in Phase 1 trials.
For more information about our early clinical
programs: www.glpg.com/other-programsFor information about the
studies with GLPG3667 in psoriasis (NCT04594928):
www.clinicaltrials.gov
About GalapagosGalapagos NV
discovers and develops small molecule medicines with novel modes of
action, several of which show promising patient results and are
currently in late-stage development in multiple diseases. Our
pipeline comprises discovery through Phase 3 programs in
inflammation, fibrosis and other indications. Our ambition is to
become a leading global biopharmaceutical company focused on the
discovery, development and commercialization of innovative
medicines. More information at www.glpg.com.
Contacts
Investors:Elizabeth GoodwinVP Investor
Relations +1 781 460 1784
Sofie Van GijselSenior Director Investor Relations+32 485
191415ir@glpg.com
Media:Carmen VroonenGlobal Head Communications
& Public Affairs+32 473 824 874
Anna GibbinsSenior Director Therapeutic Areas Communications+44
7717 801900communications@glpg.com
Forward-looking statements
This press release includes forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995, as amended, that are subject to risks,
uncertainties and other factors that could cause actual results to
differ materially from those referred to in the forward-looking
statements and, therefore, the reader should not place undue
reliance on them. These risks, uncertainties and other factors
include, without limitation, the risk that ongoing and future
clinical studies with GLPG3667 may not be completed in the
currently envisaged timelines or at all, 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 may not support registration or further development of
GLPG3667 due to safety, efficacy or other reasons), that Galapagos’
may not be able to fulfil its strategic ambition to bring therapies
with different mechanism of action to patients with inflammatory
diseases, Galapagos' reliance on collaborations with third parties
and that Galapagos’ estimations regarding its GLPG3667 development
program and regarding the commercial potential of GLPG3667, may be
incorrect, as well as those risks and uncertainties identified in
our Annual Report on Form 20-F for the year ended 31 December 2019
and our subsequent filings with the SEC. All statements other than
statements of historical fact are statements that could be deemed
forward-looking statements. The forward-looking statements
contained herein are based on management’s current expectations and
beliefs and speak only as of the date hereof, and Galapagos makes
no commitment to update or publicly release any revisions to
forward-looking statements in order to reflect new information or
subsequent events, circumstances or changes in expectations.
- First patient dosed with GLPG3667 in psoriasis patient Phase 1b
trial
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