-- Data Presented at the European League
Against Rheumatism, EULAR, European E-Congress of Rheumatology
2020 --
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.
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20200605005485/en/
“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 who were 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)1
In 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) 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)2
Nearly 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)3
Finally, 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 p40, 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
Collaboration4
Gilead 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 Galapagos
Galapagos NV (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. 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
Statement
This 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 Galapagos’ product candidates. 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.
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, European 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, European 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, European 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)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200605005485/en/
Gilead Douglas Maffei, PhD, Investors +1 (650)
522-2739
Sonia Choi, Media +1 (650) 425-5483
Galapagos Elizabeth Goodwin, Investors +1 (781)
460-1784
Carmen Vroonen, Media +32 473 824 874
Gilead Sciences (NASDAQ:GILD)
Historical Stock Chart
From Mar 2024 to Apr 2024
Gilead Sciences (NASDAQ:GILD)
Historical Stock Chart
From Apr 2023 to Apr 2024