Galapagos announces first dosing with Toledo compound GLPG3970 in psoriasis trial
September 29 2020 - 4:01PM
- TOL2/3 inhibitor most advanced compound in novel target class
with dual action in inflammatory diseases
- Patient trials initiated with GLPG3970 in psoriasis, ulcerative
colitis, and rheumatoid arthritis
- Toledo class target to be disclosed at Toledo Roundtable on 27
October 2020
Mechelen, Belgium; 29 September 2020,
22.01 CET – Galapagos NV (Euronext & NASDAQ: GLPG) announces
dosing of a first patient in their psoriasis trial, one of three
patient trials currently recruiting to evaluate efficacy and safety
of Toledo compound GLPG3970. Furthermore, Galapagos plans to unveil
the novel Toledo target class and share GLPG3970 Phase 1 data at
its inaugural Toledo Roundtable to be held virtually on 27 October
2020.
“We are excited by the rapid progress of
GLPG3970 in the clinic,” said Dr. Piet Wigerinck, Chief Scientific
Officer at Galapagos. “We now have multiple proof of concept
studies running in parallel in several autoimmune diseases, and we
aim to launch 2 additional Phase 2 studies, in Sjögren’s and
systemic lupus erythematosus, early next year, further broadening
the scope of the program. We have observed the dual mode of action
of GLPG3970 in healthy volunteers, and through these patient
trials, we aim to learn quickly whether clinical experience bears
out the potential of our Toledo program to become a new paradigm in
the treatment of inflammatory diseases.”
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 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 arthritisThis 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. Recruitment will take place in Europe.
Toledo Roundtable 27 October
2020Galapagos cordially invites institutional investors
and analysts to attend our inaugural Roundtable dedicated to
Toledo. The one-hour Roundtable will be webcast on 27 October 2020,
starting at 16.00 CET/9 am ET. Please RSVP to ir@glpg.com.
About Toledo
“Toledo” is a code name for a novel target class
discovered by Galapagos for autoimmune and fibrotic diseases. This
Toledo platform delivers small molecule inhibitors of Toledo
targets with different selectivity profiles. GLPG3970 has
immunomodulatory activity with a dual mode of action characterized
by enhanced transcription of anti-inflammatory cytokines and
inhibited transcription of pro-inflammatory cytokines. GLPG3970 has
shown encouraging preclinical activity in a number of inflammatory
diseases, including inflammatory bowel diseases, rheumatoid
arthritis, and psoriasis. Galapagos is executing on a broad program
to discover and develop multiple series of compounds with different
selectivity on Toledo targets, aimed at treating a broad range of
autoimmune conditions with still important unmet medical need.
GLPG3970 is an investigational drug and its
efficacy and safety have not been established.
For information about clinical trials with
GLPG3970: www.clinicaltrials.gov.
About GalapagosGalapagos
(Euronext & NASDAQ: GLPG) discovers and develops small molecule
medicines with novel modes of action, three of which show promising
patient results and are currently in late-stage development in
multiple diseases. The company’s pipeline comprises Phase 3 through
to discovery programs in inflammation, fibrosis, osteoarthritis 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 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 due to safety, efficacy or other reasons), Galapagos'
reliance on collaborations with third parties and that Galapagos’
estimations regarding its GLPG3970 development program and
regarding the commercial potential of GLPG3970, 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
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