-- Data Were Presented at the European
League Against Rheumatism, EULAR, European E-Congress of
Rheumatology 2020 --
Foster City, Calif., & Mechelen,
Belgium, 5 June 2020, 22.01 CET – Gilead Sciences, Inc.
(Nasdaq: GILD) and Galapagos NV (Euronext & Nasdaq: GLPG) today
announced new analyses from two clinical trials evaluating
filgotinib, an investigational, oral, selective JAK1 inhibitor, in
adults with psoriatic arthritis (PsA). The data from the
double-blind, placebo-controlled, Phase 2 EQUATOR study and the
EQUATOR-2 open-label extension study demonstrate filgotinib’s
durable efficacy and consistent safety profile in people with
active PsA, and showed rapid and sustained reductions in
inflammatory biomarkers in patients with moderate to severe PsA.
The new analyses were presented at the European League Against
Rheumatism, EULAR, European E-Congress of Rheumatology 2020.
“Despite existing treatments, people living with
psoriatic arthritis can face challenging long-term symptoms
including joint swelling and stiffness, pain and fatigue – all of
which can significantly impact patients’ daily lives,” said Mark
Genovese, MD, Senior Vice President, Inflammation, Gilead Sciences.
“These new analyses from the EQUATOR study program showed that
patients with PsA treated with filgotinib achieved a sustained
response. We look forward to advancing the pivotal Phase 3 PENGUIN
clinical trial program to confirm the safety and efficacy of
filgotinib as a potential treatment option for this patient
population.”
“The data from the Phase 2 program for
filgotinib in psoriatic arthritis add to the growing body of
evidence for the efficacy and safety profile of this
investigational treatment,” said Walid Abi-Saab, MD, Chief Medical
Officer, Galapagos. “We are particularly encouraged by the
innovative analysis of the impact of filgotinib at the molecular
level, which indicates the drug is acting rapidly to reduce the
hallmarks of inflammation in this condition.”
Efficacy and safety of filgotinib in patients
with active PsA: Subgroup analyses from a randomized,
placebo-controlled, Phase 2 trial (EQUATOR) (Poster #0343)1In a new
subgroup analysis of patients with active PsA in the 16-week
EQUATOR Phase 2 trial, the effects of filgotinib on key efficacy
endpoints were generally consistent across a range of patient
subgroups, including sex, body mass index, disease duration,
baseline disease severity, concurrent use of disease-modifying
antirheumatic drugs and prior exposure to tumor necrosis factor
inhibitors.
Filgotinib consistently demonstrated a
statistically significant higher proportion of patients achieving
ACR20 response compared with placebo across all subgroups.
Similarly, filgotinib achieved a higher proportion of ACR50
response and Psoriatic Arthritis Disease Activity Score (PASDAS) of
low disease activity, compared with placebo, reaching statistical
significance in most subgroups. Treatment differences for Disease
Activity Index for Psoriatic Arthritis (DAPSA) consistently favored
filgotinib, reaching statistical significance in most subgroups as
well. There were no clinically relevant differences when comparing
response to filgotinib across subgroups.
Filgotinib demonstrated a consistent safety
profile and no new safety signals were identified in this
study.
Long-term efficacy of filgotinib in PsA: Week 52
response patterns from an open-label extension (OLE) study
(EQUATOR-2) (Poster #0339)2Nearly all (98.4 percent, 122/124) of
the patients who completed the 16-week EQUATOR trial enrolled in
the EQUATOR-2 OLE study. The median exposure to filgotinib in both
EQUATOR and the OLE study was 66 weeks. An interim analysis at Week
52 demonstrated sustained efficacy with filgotinib across several
measures of disease activity and treatment response in patients
with active PsA.
The majority of patients who achieved minimal
disease activity (MDA) and ACR50 response in the original EQUATOR
trial maintained MDA and ACR50 at Week 52 and a proportion of
non-responders in EQUATOR achieved these responses in the OLE
study. In total, at Week 52 of the OLE study, 33.6 percent of
patients achieved MDA response and 55.0 percent achieved ACR50
response in this observed case analysis. No new safety signals were
observed.
Effect of filgotinib on inflammatory biomarkers
in patients with moderate to severe PsA (Oral #0224)3Finally, in a
new biomarker analysis of samples from the EQUATOR trial, treatment
with filgotinib demonstrated significantly greater reductions from
baseline in levels of circulating biomarkers associated with PsA
disease activity, compared with placebo. Filgotinib treatment
reduced cytokines involved in both systemic inflammation, such as
IL-6 and SAA, as well as psoriasis-associated pathology, such as
IL-17AF and IL-12, reflecting the improvements in clinical scores
observed in EQUATOR. These findings are consistent with reduced
disease activity in patients with PsA and suggest that filgotinib
treatment leads to a sustained reduction of inflammation in
PsA.
Filgotinib is an investigational agent and is
not approved by the FDA or any other regulatory authority. For
information about the clinical trials with filgotinib, visit
www.clinicaltrials.gov.
About the Filgotinib
Collaboration4Gilead and Galapagos are collaborative
partners in the global development and commercialization of
filgotinib in RA, and other inflammatory indications. The companies
have multiple clinical study programs for filgotinib in
inflammatory diseases, including the FINCH Phase 3 program in
rheumatoid arthritis, the Phase 3 SELECTION trial in ulcerative
colitis, the DIVERSITY Phase 3 trial in Crohn’s disease, the Phase
3 PENGUIN trials in psoriatic arthritis, as well as Phase 2 studies
in uveitis and in small bowel and fistulizing Crohn’s disease. More
information about clinical trials with filgotinib can be accessed
at: www.clinicaltrials.gov.
About Gilead Sciences
Gilead Sciences, Inc. is a research-based
biopharmaceutical company that discovers, develops and
commercializes innovative medicines in areas of unmet medical need.
The company strives to transform and simplify care for people with
life-threatening illnesses around the world. Gilead has operations
in more than 35 countries worldwide, with headquarters
in Foster City, California. For more information on Gilead
Sciences, please visit the company’s website at www.gilead.com.
About GalapagosGalapagos NV
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. Our
pipeline comprises discovery through Phase 3 programs in
inflammation, fibrosis, osteoarthritis 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.
Gilead Forward-Looking
StatementThis press release includes forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995 that are subject to risks, uncertainties and
other factors, including the possibility of unfavorable results
from ongoing and additional clinical trials involving filgotinib and
the possibility that we are unable to complete one or more of such
trials on the currently anticipated timelines. Further, it is
possible that the parties may make a strategic decision to
discontinue development of filgotinib, and as a result, filgotinib
may never be successfully commercialized. All statements other than
statements of historical fact are statements that could be deemed
forward-looking statements. These risks, uncertainties and other
factors could cause actual results to differ materially from those
referred to in the forward-looking statements. The reader is
cautioned not to rely on these forward-looking statements. These
and other risks are described in detail in Gilead’s Form 10-Q for
the quarter ended March 31, 2020, as filed with the U.S. Securities
and Exchange Commission. All forward-looking statements are based
on information currently available to Gilead, and Gilead assumes no
obligation to update any such forward-looking statements.
Galapagos Forward-Looking Statement
This release may contain forward-looking
statements with respect to Galapagos, including statements
regarding Galapagos’ strategic ambitions, the mechanism of action
and potential safety and efficacy of filgotinib, the anticipated
timing of clinical studies with filgotinib and the progression and
results of such studies. Galapagos cautions the reader that
forward-looking statements are not guarantees of future
performance. Forward-looking statements involve known and unknown
risks, uncertainties and other factors which might cause the actual
results, financial condition and liquidity, performance or
achievements of Galapagos, or industry results, to be materially
different from any historic or future results, financial conditions
and liquidity, performance or achievements expressed or implied by
such forward-looking statements. In addition, even if Galapagos’
results, performance, financial condition and liquidity, and the
development of the industry in which it operates are consistent
with such forward-looking statements, they may not be predictive of
results or developments in future periods. Among the factors
that may result in differences are 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
filgotinib due to safety, efficacy or other reasons), Galapagos’
reliance on collaborations with third parties (including its
collaboration partner for filgotinib, Gilead), and estimating the
commercial potential of filgotinib. A further list and description
of these risks, uncertainties and other risks can be found in
Galapagos’ Securities and Exchange Commission (SEC) filings and
reports, including in Galapagos’ most recent annual report on form
20-F filed with the SEC and subsequent filings and reports filed by
Galapagos with the SEC. Given these uncertainties, the reader
is advised not to place any undue reliance on such forward-looking
statements. These forward-looking statements speak only as of the
date of publication of this document. Galapagos expressly disclaims
any obligation to update any such forward-looking statements in
this document to reflect any change in its expectations with regard
thereto or any change in events, conditions or circumstances on
which any such statement is based or that may affect the likelihood
that actual results will differ from those set forth in the
forward-looking statements, unless specifically required by law or
regulation.
# # #
Contacts Galapagos
Investors:
Media:Elizabeth
Goodwin Carmen
Vroonen VP
IR
Senior Director Communications & Public Affairs+1 781 460
1784
+32 473 824
874
Sofie Van Gijsel
Evelyn FoxDirector IR
Director Communications+32 485 19 14
15
+31 6 53 591
999ir@glpg.com
communications@glpg.com
Contacts
GileadInvestors:
Media:Douglas Maffei,
PhD
Sonia Choi+1 650 522
2739
+1 650 425 5483
1 Helliwell PS, et al. Efficacy and safety of filgotinib, a
selective Janus kinase 1 inhibitor, in patients with active
psoriatic arthritis: Subgroup analyses from a randomized,
placebo-controlled, Phase 2 trial (EQUATOR) Abstract at the
European League Against Rheumatism (EULAR), E-Congress of
Rheumatology 2020.
2 Gladman DD, et al. Long-term efficacy of the oral selective
Janus kinase 1 inhibitor filgotinib in psoriatic arthritis: Week 52
response patterns in individual patients from an open-label
extension (OLE) study (EQUATOR2). Abstract at the European League
Against Rheumatism (EULAR), E-Congress of Rheumatology
2020.
3 Gladman D, et al. Filgotinib treatment leads to rapid and
sustained reductions in inflammatory biomarkers in patients with
moderate to severe psoriatic arthritis. Abstract at the European
League Against Rheumatism (EULAR), E-Congress of Rheumatology
2020.
4 Gilead & Galapagos Filgotinib Clinical Program Trial
Details: FINCH 1 (NCT02889796); FINCH 2 (NCT02873936); FINCH 3
(NCT02886728); SELECTION (NCT02914522); DIVERSITY (NCT02914561);
PENGUIN 1 (NCT04115748); PENGUIN 2 (NCT04115839)
Galapagos (EU:GLPG)
Historical Stock Chart
From Jun 2024 to Jul 2024
Galapagos (EU:GLPG)
Historical Stock Chart
From Jul 2023 to Jul 2024