Galapagos announces start of Phase 2 study with selective TYK2 inhibitor, GLPG3667, in patients with active systemic lupus erythematosus
28 Agosto 2023 - 10:01PM
- GLPG3667 is an investigational, novel, oral,
reversible, and selective tyrosine kinase 2 (TYK2)
inhibitor
- GLPG3667 is currently in development for the treatment
of inflammatory and auto-immune diseases and is in
Phase 2 for
dermatomyositis
Mechelen, Belgium; 28 August 2023,
22.01 CET; Galapagos NV (Euronext & NASDAQ: GLPG) today
announced that the first patient was randomized in
GALACELA, a Phase 2 systemic
lupus erythematosus (SLE) trial with GLPG3667.
The GALACELA Phase 2 trial (NCT05856448) is a randomized,
double-blind, placebo-controlled, multi-center study to evaluate
the efficacy, safety, tolerability, pharmacokinetics and
pharmacodynamics of GLPG3667 in adults with active SLE. A
once-daily oral administration of GLPG3667 or placebo will be
investigated in approximately 140 adult patients with SLE for 32
weeks. The primary endpoint is the proportion of patients who
achieve the SLE responder index (SRI)-4 response at Week
32. The secondary efficacy endpoints are the proportion of
patients who achieve the British Isles Lupus Assessment Group
(BILAG)-based Composite Lupus Assessment (BICLA) response at Week
32, proportion of patients with >=50% reduction in Cutaneous
Lupus Erythematosus Disease Area and Severity Index Activity
(CLASI-A) score at Week 16, proportion of patients who achieve
Lupus Low Disease Activity State (LLDAS) at Week 32 and change from
baseline in the 28-joint count for tender, swollen, and tender and
swollen (active) joints at Week 32.
“We are proud to have reached this important milestone in our
journey to improve the lives of patients living with autoimmune
diseases. Although significant progress has been made in the
management of SLE over the past decade, flares, morbidity, and
mortality continue to remain a significant concern and quality of
life is poor among patients living with SLE,” said Daniele
D’Ambrosio, MD, PhD, Therapeutic Area Head Immunology, at
Galapagos. “We are excited about GLPG3667’s potential to make a
meaningful difference for people living with SLE and look forward
to advancing this candidate medicine in clinical
development.”
GLPG3667 is an investigational drug and is not approved by any
regulatory authority. Its efficacy and safety have not been
established or fully evaluated by any regulatory
authority.
About systemic lupus erythematosus (SLE)SLE is
a chronic, inflammatory, autoimmune disease affecting nearly every
organ system and thereby one of the most heterogeneous illnesses
treated by physicians1. The pathogenesis of SLE is characterized by
a global loss of self-tolerance with activation of autoreactive T
and B cells. This leads to the production of pathogenic
autoantibodies that primarily target a variety of nuclear antigens,
deposit in tissues and activate complement, resulting in organ
damage. SLE affects women more frequently than men and is more
prevalent and severe (with higher disease activity and more damage
accrual) in non-Caucasian populations (Hispanics, African
descendants, and Asians)2. SLE has periods of relatively stable
disease followed by flares that may induce irreversible organ
damage. Despite best practice, most patients accrue irreversible
organ damage within 7 years of diagnosis. SLE has no cure and
current treatment options are associated with partial efficacy
and/or substantial toxicities. New treatments may help to fulfill
the current unmet medical needs among patients.
About GalapagosGalapagos is a fully integrated
biotechnology company united around a single purpose: to transform
patient outcomes through life-changing science and innovation for
more years of life and quality of life. We focus on the key
therapeutic areas of immunology and oncology, where we have
developed deep scientific expertise in multiple drug modalities,
including small molecules and cell therapies. Our portfolio
comprises discovery through to commercialized programs and our
first medicine for rheumatoid arthritis and ulcerative colitis is
currently available in Europe and Japan. For additional
information, please visit www.glpg.com or follow us
on LinkedIn or Twitter.
Contact
Media
inquiriesMarieke
Vermeersch +32 479 490
603 media@glpg.com |
Investor
inquiriesSofie Van Gijsel +1
781 296 11433ir@glpg.comSandra Cauwenberghs ir@glpg.com |
Forward-looking statements
This press release includes forward-looking
statements, all of which involve certain risks and uncertainties.
These statements are often, but not always, made through the use of
words or expressions such as “start,” “potential,” “remains,”
“develop,” advance,” “continue,” “will,” “can,” “forward,” and
“improve,” as well as similar expressions. Forward-looking
statements contained in this press release include, but are not
limited to, statements regarding
the preliminary, interim and topline data
from our studies, including, without any limitation, the
GALACELA study, and all other analyses related to GLPG3667
or our immunology portfolio, statements regarding our
plans and strategy with respect to GLPG3667 or our
immunology portfolio, including, without any limitation,
the GALACELA study, statements regarding the expected
timing, design and readouts of the GALACELA study,
including the recruitment for trials and timing
for topline results, and statements regarding our R&D
and regulatory outlook. Any forward-looking statements in
this press release are based on our management’s current
expectations and beliefs, and are not guarantees of future
performance. Forward-looking statements may involve known and
unknown risks, uncertainties and other factors which might cause
our actual results, performance or achievements to be materially
different from any historic or future results, performance or
achievements expressed or implied by such statements. These
risks, uncertainties and other factors include, without any
limitation, the risk that ongoing and future clinical
studies (including the GALACELA study) may not be
completed in the currently envisaged timelines or at all, the
inherent risks and uncertainties associated
with competitive developments, clinical trials,
recruitment of patients, product development activities and
regulatory approval requirements (including, without any
limitation, that data from ongoing and planned clinical research
programs, including, without any limitation, the data from the
ongoing GALACELA study, may not support further
development or registration due to safety, efficacy, or other
reasons, or that data readouts in the future may not reflect
interim data results), the inherent risks and uncertainties
associated with target discovery and validation or drug discovery
and development activities, the risks related to our
reliance on collaborations with third parties, and the
risk that we will not be able to continue to execute on our
currently contemplated business plan and/or will revise our
business plan. A further list and description of these
risks, uncertainties and other factors can be
found in our filings and reports with the Securities and Exchange
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by any other filings and reports that we have made or will make
with the SEC in the future. Given these risks and
uncertainties, the reader is advised not to place any undue
reliance on forward-looking statements. In addition, even if our
results, performance or achievements are consistent with such
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update any forward-looking statements in this press release, unless
required by law or regulation.
1 Rees, F. et al., (2017). The worldwide incidence and
prevalence of systemic lupus erythematosus: a systematic review of
epidemiological studies. Rheumatol. Oxf. Engl., 56(11), 1945–1961.2
González, L. A. et al (2013). Ethnicity in systemic lupus
erythematosus (SLE): its influence on susceptibility and outcomes.
Lupus, 22(12), 1214–1224.
- Galapagos announces start of Phase 2 study with selective TYK2
inhibitor, GLPG3667, in patients with active systemic lupus
erythematosus
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