Galapagos’ R&D Roundtable showcases Toledo program
October 27 2020 - 11:20AM
- Comprehensive preclinical package
elucidates dual mode of action (MoA) and potential broad
applicability of salt-inducible kinase (SIK) inhibitors in
inflammation
- Innovative chemistry generated
multiple series of SIK compounds with distinct selectivity
profiles, aimed at a range of inflammatory & fibrotic
conditions
- Phase 1 data with SIK2/3 selective
GLPG3970 confirm dose-dependent dual MoA effect
- Data package supports comprehensive
clinical development of GLPG3970 in multiple Proof of Concept
trials
Mechelen, Belgium; 27 October 2020,
16.15 CET – Galapagos NV (Euronext & NASDAQ: GLPG) unveils the
Toledo target family as a series of salt-inducible
kinase inhibitors. Toledo exhibits
a dual mode of action characterized by enhanced
transcription of anti-inflammatory cytokines and inhibited
transcription of pro-inflammatory cytokines. Today, Galapagos also
presents new preclinical and healthy volunteer data, and details
its broad program to discover and develop multiple series of Toledo
compounds with different selectivity profiles, aimed at treating a
broad range of autoimmune conditions with important unmet medical
need.
“The discovery of the SIK family of targets in
our dual layer assays a number of years ago goes hand in hand with
the scientific literature pointing to a dual mode of action of SIKs
in inflammatory conditions,” said Dr. Piet Wigerinck, Chief
Scientific Officer at Galapagos. “Galapagos developed innovative
chemistry to address a number of selectivity profiles, and we now
also show promising preclinical activity in fibrotic models,
further broadening the scope of the Toledo program to a second
disease paradigm where we built up substantial scientific know-how
over the years. In the Phase 1 trial, we have shown a
favorable PK profile and confirmed the dual mode of action,
observing a dose-dependent effect in ex vivo healthy volunteers
with GLPG3970.”
“We generated the data package to take our first
Toledo compound, GLPG3970, confidently into multiple proof of
concept studies running in parallel. Currently the CALOSOMA study
in psoriasis, the SEA TURTLE study in ulcerative colitis, and the
LADYBUG study in rheumatoid arthritis are actively recruiting
patients, and we aim to initiate two additional Phase 2 studies in
Sjögren’s and systemic lupus erythematosus early next year,” said
Dr. Walid Abi-Saab, Chief Medical Officer at Galapagos.
“Furthermore, we continue to take a programmatic approach,
cross-learning from the different proof-of-concept studies and
biomarkers in our comprehensive development plan. Building up our
knowledge with rapid signal detection studies, we aim to understand
as well as maximize the potential of our Toledo program to become a
new paradigm in the treatment of inflammatory and fibrotic
diseases. Our development strategy is aimed at optimizing the route
of GLPG3970 to the market.”
About the GLPG3970 clinical
portfolio
CALOSOMA study: Phase 1 trial in
psoriasis The Calosoma Phase 1 trial (NCT04106297) is a
double-blind, placebo-controlled study evaluating the safety,
tolerability, PK and PD1 of GLPG3970 single and multiple ascending
doses in up to 52 adult healthy male subjects. GLPG3970 will now be
investigated for 6 weeks in 25 subjects with moderate to severe
psoriasis. The first patient was dosed recently.
SEA TURTLE study: Phase 2 trial in
ulcerative colitis (UC)This Phase 2 trial is a
double-blind, placebo-controlled study evaluating the efficacy,
safety, tolerability, PK and PD of GLPG3970 in up to 30 subjects
with moderately to severely active UC. GLPG3970 or a placebo will
be administered orally once daily for 6 weeks, with the primary
endpoint of change from baseline in total Mayo Clinical Score
(MCS).
LADYBUG study: Phase 2 trial in
rheumatoid arthritis (RA)This Phase 2 trial is a
double-blind, placebo-controlled study evaluating the efficacy,
safety, tolerability, PK and PD of GLPG3970 in up to 25
participants with severely active RA and an inadequate response to
methotrexate. GLPG3970 or a placebo will be administered orally
once-daily for 6 weeks, with the primary endpoint of change from
baseline of DAS28 CRP at week 6.
GLPG3970 is an investigational drug and its
efficacy and safety have not been established.
For information about clinical trials with
GLPG3970: www.clinicaltrials.gov.For more information about the
Toledo program: www.glpg.com/toledo-program
About GalapagosGalapagos
(Euronext & NASDAQ: GLPG) 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. The company’s pipeline comprises
early discovery through to Phase 3 programs in inflammation,
fibrosis, and other indications. Galapagos’ 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 19 14
15ir@glpg.com
Media:Carmen VroonenGlobal Head of
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 GLPG3970 and other Toledo program molecules
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 GLPG3970 and other Toledo
program molecules due to safety, efficacy or other reasons), and
that Galapagos’ estimations regarding the mode of action of
GLPG3970 and other Toledo program molecules, regarding its GLPG3970
and other Toledo program molecules development program and
regarding the commercial potential of GLPG3970 and other Toledo
program molecules, 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.
1 Pharmacokinetics and pharmacodynamics
- Galapagos’ R&D Roundtable showcases Toledo program
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