New analyses from filgotinib clinical development program
reinforce the investigational medicine’s consistent efficacy and
safety profile in the treatment of inflammatory diseases
FOSTER CITY, Calif. and Mechelen, Belgium, 31
October, 2019, 21:01 CET – Gilead Sciences, Inc. (NASDAQ: GILD)
and Galapagos NV (Euronext & NASDAQ: GLPG) today announced that
new data from across the companies’ inflammatory disease research
and development program will be presented at the 2019 American
College of Rheumatology/Association of Rheumatology Professionals
(ACR/ARP) Annual Meeting in Atlanta from November 8-13. The
companies will present 20 abstracts at this year’s meeting,
including key data on the investigational medicine filgotinib in
rheumatoid arthritis (RA) and psoriatic arthritis (PsA), as well as
real-world RA treatment outcomes and care.
“These latest data add to the growing body of
evidence on the potential role of filgotinib in the management of
rheumatoid arthritis and other inflammatory diseases,” said John
Sundy, MD, PhD, Senior Vice President, Inflammation and Respiratory
Diseases, Gilead Sciences. “People living with RA may experience
long-term symptoms that persist despite currently available
treatment options. At Gilead, we are working to help improve the
lives of people living with inflammatory conditions and look
forward to sharing these latest data at ACR/ARP.”
“We are proud to share these latest data at the
2019 ACR/ARP Annual Meeting,” said Dr. Walid Abi-Saab, Chief
Medical Officer, Galapagos. “These results continue to show the
potential for filgotinib in RA for patients who face significant
challenges living with this disease. Further, we are particularly
excited to embark on the PENGUIN Phase 3 trials in psoriatic
arthritis, as filgotinib has the potential to address the important
unmet medical need of patients living with this disease.”New
Filgotinib Efficacy and Safety Data in Rheumatoid Arthritis
Key presentations include multiple subgroup
analyses from the FINCH 2 clinical trial that demonstrate the
potential of filgotinib across specific RA populations who have
experienced an inadequate response to biologic disease-modifying
anti-rheumatic drugs (bDMARDs), including those in this
difficult-to-treat population with anemia, thrombocytopenia and
leukopenia. Key data will also include pooled safety results from
the Phase 3 FINCH program (NCT02889796, NCT02873936, NCT02886728),
and safety outcomes from the long-term DARWIN-3 trial
(NCT02065700).
- A Subgroup Analysis of the Efficacy of Filgotinib in
Demographic and Clinical Subgroups of Patients with Refractory
Rheumatoid Arthritis (Poster, #504, Sunday, Nov. 10; 9:00am)
- A Subgroup Analysis of Clinical Efficacy Response and Quality
of Life Outcomes from Phase 3 Study of Filgotinib in Patients with
Inadequate Response to Biologic DMARDs (Poster, #517, Sunday, Nov.
10; 9:00am)
- Effects of Filgotinib on Anemia, Thrombocytopenia and
Leukopenia: Results from a Phase 3 Study in Patients with Active
Rheumatoid Arthritis and Prior Inadequate Response or Intolerance
to Biologic DMARDs (Oral, #2875, Wednesday, Nov. 13; 9:00am)
- Pooled Safety Analyses from Phase 3 Studies of Filgotinib in
Patients with Rheumatoid Arthritis (Poster, #1329, Monday, Nov. 11;
9:00am)
- Rheumatoid Arthritis Treatment with Filgotinib: Week 156 Safety
and Efficacy Data from a Phase 2b Open-Label Extension Study
(Poster, #550, Sunday, Nov. 10; 9:00am)
In RA, biomarker research seeks to better
characterize the molecular basis of the disease and identify
populations that may benefit most from a treatment. Gilead is
committed to helping drive forward this emerging area of
innovation. Presented data will assess the relationship between a
series of RA biomarkers and the therapeutic response of
filgotinib.
- bDMARD-Experienced Filgotinib-Treated Patient Samples Exhibit a
Partial Reversion to the Peripheral Molecular Profile of a
Demographically Matched Healthy Population (Poster, #45, Sunday,
Nov. 10; 9:00am)
- Key Inflammatory Biomarkers at Baseline are Associated with
Filgotinib Response at Week 12 in Rheumatoid Arthritis Patients
with Inadequate Response or Intolerance to Biologic DMARDs (Poster,
#46, Sunday, Nov. 10; 9:00am)
- A Composite IFN-Based Signature is Associated with a
Filgotinib-Specific Clinical Response in bDMARD-Experienced
Rheumatoid Arthritis Patients (Poster, #2012, Tuesday, Nov. 12;
9:00am)
Real-World Treatment Experiences in
Rheumatoid ArthritisIn addition to therapeutic innovation,
increased understanding of the real-world experiences of patients
living with RA is needed. Select data will highlight results from
multiple studies focused on the overall burden of RA within the
U.S.
- Treatment Patterns and Persistency Following First Biologic
DMARD in Patients with Rheumatoid Arthritis: Real-World Analysis of
2012-2016 U.S. Medicare data (Oral, #953, Sunday, Nov. 10;
4:30pm)
- Real-World Evidence: Clinical and Economic Burden of Anemia,
Venous Thromboembolism, and Malignancy Among Rheumatoid Arthritis
Patients Switching from First Biologic DMARD to Another Treatment
in the U.S. (Poster, #204, Sunday, Nov. 10; 9:00am)
- Real-World Evidence: Infections Among Rheumatoid Arthritis
Patients Switching from First Biologic DMARD to Another Treatment
in the U.S. (Poster, #1374, Monday, Nov. 11; 9:00am)
Filgotinib in Psoriatic Arthritis
Long-Term Safety with Filgotinib in PsAIt
is important to understand the safety profile as well as the
durability of response to new therapeutic options across potential
indications. Results from a long-term safety analysis evaluating
the safety of filgotinib for people with PsA will be presented.
- Long-Term Safety of Filgotinib in Patients with Psoriatic
Arthritis, Week 52 Safety Data from a Phase 2 Open-Label Extension
Study (Poster, #1534, Monday, Nov. 11; 9:00am)
Initiation of PENGUIN Phase 3 Program with Filgotinib in
PsA
The efficacy and safety of 100 mg and 200 mg
filgotinib once-daily compared to placebo will now be further
investigated in the PENGUIN Phase 3 program. PENGUIN 1
(NCT04115748) will compare the efficacy and safety of filgotinib,
adalimumab and placebo in approximately 1000 patients with active
PsA who are naive to bDMARD therapy. PENGUIN 2 (NCT04115839) will
measure efficacy and safety of filgotinib vs placebo in 390
patients with active PsA who have an inadequate response or are
intolerant to bDMARD therapy. The primary endpoint of each trial is
ACR20 response at week 12, with multiple secondary endpoints on
signs and symptoms of PsA up to week 24 in PENGUIN 1, and week 16
in PENGUIN 2.
Filgotinib is an investigational agent and is
not approved by the U.S. Food and Drug Administration or any other
regulatory authority. Its efficacy and safety have not been
established.
For more information, including a complete list of the abstracts
being presented at the 2019 ACR/ARP annual meeting, please visit:
https://acrabstracts.org.
For information about clinical trials with
filgotinib, please visit: www.clinicaltrials.gov.
About the Filgotinib Collaboration
Galapagos and Gilead entered into a global
collaboration for the development and commercialization of
filgotinib in inflammatory indications. The FINCH studies in
rheumatoid arthritis are among several clinical trials of
filgotinib in inflammatory diseases, which also include the EQUATOR
Phase 2 program in psoriatic arthritis, the TORTUGA study in
ankylosing spondylitis, the DIVERSITY Phase 3 trial (NCT02914561)
in Crohn’s disease (also small bowel and fistulizing Crohn’s
disease Phase 2 studies), the Phase 3 SELECTION trial (NCT02914522)
in ulcerative colitis and the Phase 3 PENGUIN trial in psoriatic
arthritis.
About Galapagos
Galapagos (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.
Galapagos’ pipeline comprises Phase 3 through to discovery programs
in inflammation, fibrosis, osteoarthritis and other indications.
The Company’s ambition is to become a leading global
biopharmaceutical company focused on the discovery, development and
commercialization of innovative medicines.
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.
CONTACTS:
Gilead
GalapagosGreg Mann, Investors
Elizabeth Goodwin, Investors (424)
322-1795
(781) 460-1784 Arran Attridge,
Media
Carmen Vroonen, Media (650) 425-8975
+32 473 824 874
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.
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 Quarterly
Report on Form 10-Q for the quarter ended June 30, 2019, 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 (EU:GLPG)
Historical Stock Chart
From Jun 2024 to Jul 2024
Galapagos (EU:GLPG)
Historical Stock Chart
From Jul 2023 to Jul 2024