- Biologic effect of
salt inducible kinase
(SIK)
mechanism in
first patient
studies supports further
progression of Toledo portfolio
- SIK2/3 inhibitor
GLPG3970
generally safe and
well-tolerated
- Study in psoriasis
patients shows
improvement in PASI score at Week
6
- Study in ulcerative colitis
(UC) patients
shows signs of biologically
important effects; does not
translate to signal on Mayo score at Week
6
- No signal observed in rheumatoid
arthritis
(RA)
study at Week 6
Mechelen, Belgium;
14 July 2021;
22.01
CET; regulated
information – Galapagos
NV (Euronext &
Nasdaq:
GLPG) reports topline
results with GLPG3970 in
three
patient
studies.
GLPG3970, the
first product candidate from a
broad portfolio of SIK inhibitor
compounds, provides clinical data
supporting the role of SIK inhibition in
inflammation. SIK is a novel target class
discovered by
Galapagos.
Galapagos evaluated GLPG3970, a proprietary salt
inducible kinase (SIK) 2/3 inhibitor, in three randomized,
placebo-controlled, double-blind studies: a Phase 1b study in
patients with moderate to severe psoriasis and two Phase 2a studies
in patients with moderate to severely active UC and RA. GLPG3970 or
placebo were administered orally once-daily for 6 weeks. Main
objectives were to evaluate the safety and tolerability of GLPG3970
as well as early signs of biologic and clinical effect.
Across the three studies, GLPG3970 was generally
safe and well tolerated. There were no deaths nor serious adverse
events, and the majority of treatment emergent adverse
events (TEAEs) were mild or moderate in nature.
CALOSOMA study: Phase
1b trial in
psoriasisThis study randomized 26 patients with moderate
to severe psoriasis in a 3:2 ratio, GLPG3970 to placebo.
Two out of 15 patients discontinued in the treatment arm
(COVID-19 and pruritus) versus 1 out of 11 on
placebo (psoriatic arthropathy).
At Week 6, four out of 13 patients on GLPG3970
had a PASI1 50 response, defined as at least a 50% improvement of
baseline PASI, compared to none on placebo. Specifically, the four
responders achieved 50%, 50%, 56%, and 77% improvement in their
PASI scores from baseline, reaching statistical significance
compared to placebo (p=0.002) at Week 6. Positive signals of
clinical effect were also consistently observed for other
endpoints, including affected Body Surface Area and physician and
patient global assessment, versus placebo at Week 6.
SEA TURTLE study: Phase 2a trial
in UCThis study randomized 31
biologic-naïve patients with moderate to severely active UC in a
2:1 ratio, GLPG3970 to placebo. One out of 21 patients
discontinued in the active treatment arm (COVID-19)
versus one out of 10 on placebo (QT abnormality at
baseline).
At Week 6, positive signals were observed in
patients on GLPG3970 on objective parameters such as endoscopy,
histology, and fecal calprotectin. These findings did not translate
in a differentiation from placebo on change from baseline total
Mayo Clinic Score in this 6-week study (GLPG3970 -2.7, placebo
-2.6). Seven out of 18 patients on GLPG3970 who underwent endoscopy
at Week 6 met the criteria for Endoscopic Improvement, defined as a
score of 0 or 1 on the endoscopic response score, compared to one
out of 9 patients on placebo. The robustness of these signals will
be further examined when additional efficacy and biomarker data
become available later this year.
LADYBUG study: Phase
2a trial in
RAThis study randomized 28 patients with moderate
to severely active RA and an inadequate response to methotrexate in
a 3:2 ratio, GLPG3970 to placebo. Three out of 16 patients
discontinued in the treatment arm (COVID-19, ALT
increase and physician decision) versus 2 out of 12
on placebo (COVID-19).
At Week 6, patients on GLPG3970 showed no
differentiation from placebo on change from baseline DAS28 (CRP)2
response (GLPG3970 -1.29, placebo -1.24), nor on the majority of
other efficacy endpoints.
Further development of Toledo
product portfolioGLPG3970 is the
first compound from Galapagos’ broad portfolio of novel molecules
to provide clinical evidence for the potential role of SIK
inhibition in inflammation. Biomarker data from these
signal-finding studies with GLPG3970 will be further analyzed for
signature profiles. Our aim with the Toledo program is
to explore this novel mode of action fully and
bring forward improved molecules directed toward SIK2/3 as
well as other SIK selectivity profiles. Galapagos
currently has two compounds exhibiting SIK2/3 inhibition in
preclinical development.
“We are excited to demonstrate, for the first
time, important biologic and clinical effects with a SIK inhibitor
in patients with inflammatory conditions. This is a major
achievement when working on a novel mode of action target class.
The CALOSOMA trial in psoriasis patients indicates clear proof of
activity and the SEA TURTLE trial in ulcerative colitis patients
provides encouraging results that support further development with
Toledo compounds with improved pharmacology. In addition, these
studies in patients confirm the safety and tolerability profile
previously observed in healthy volunteers,” said Dr. Walid
Abi-Saab, Chief Medical Officer of Galapagos. “The GLPG3970 broad
dataset is an important step forward, and we aim to apply key
learnings from these studies to the further development of our
Toledo portfolio of SIK inhibitors.”
Galapagos intends to submit study outcomes with
GLPG3970 for publication at scientific conferences and in
peer-reviewed medical journals.
About Toledo“Toledo” is an
extensive program with a novel target class, SIK, whose potential
role in inflammation was discovered by Galapagos. The Toledo
program aims to treat a broad range of autoimmune conditions with
important unmet medical needs. The Toledo platform delivers small
molecule inhibitors of SIK targets with different selectivity
profiles. The most advanced compound, SIK2/3 inhibitor GLPG3970,
has shown immunomodulatory activity in vitro preclinically and ex
vivo clinically with what Galapagos believes is a dual mode of
action characterized by enhanced transcription of anti-inflammatory
cytokines and inhibited transcription of pro-inflammatory
cytokines. SIK inhibition has previously shown encouraging
preclinical activity in a range of inflammatory disease models.
GLPG3970 is an investigational drug and not
approved by any regulatory authority. Its efficacy and safety have
not been established.
About GalapagosGalapagos NV
(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 clinical 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.
This press release contains inside information
within the meaning of Regulation (EU) No 596/2014 of the European
Parliament and of the Council of 16 April 2014 on market abuse
(market abuse regulation).
Contacts Investors:Elizabeth
GoodwinVP Investor Relations +1 781 460 1784
Sofie Van GijselSenior Director Investor Relations+1 781 296
1143 ir@glpg.com
Media:Kyra ObolenskySenior Director Corporate
Communications+32 491 92 64 35
Evelyn FoxDirector Executive Communications+31 65 3591
999communications@glpg.com
Galapagos 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 as well as regarding
its Toledo platform, 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 2020 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 Psoriasis Area and Severity Index; an index used to
express the severity of psoriasis. It combines the severity
(erythema, induration and desquamation) and percentage of affected
area
2 DAS28 is a RA Disease Activity Score based on a calculation
that uses tender and swollen joint counts of 28 defined joints, the
physician’s global health assessment and a serum marker for
inflammation, such as C-reactive protein. DAS28 (CRP) includes the
C-reactive protein score calculation
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