-- FINCH 2 Study Results Demonstrate
Significant Improvement in Rheumatoid Arthritis Signs, Symptoms and
Health-Related Quality of Life –
Gilead Sciences, Inc. (Nasdaq: GILD) and Galapagos NV (Euronext
& NASDAQ: GLPG) today announced detailed results from the Phase
3 FINCH 2 clinical trial of filgotinib, an investigational,
selective JAK1 inhibitor, in adults with moderately-to-severely
active rheumatoid arthritis and prior inadequate response or
intolerance to biologic agents. The data, which are being presented
as a late-breaking poster at the 2018 American College of
Rheumatology/Association of Rheumatology Health Professionals
(ACR/ARHP) Annual Meeting in Chicago, suggest filgotinib has a
potential role in addressing important unmet needs in the treatment
of rheumatoid arthritis.
Positive efficacy data from FINCH 2 were previously announced in
September 2018. The data show statistically significant
improvements in the proportion of patients achieving a range of
clinical efficacy endpoints, including the proportion of patients
achieving American College of Rheumatology 20 percent (ACR20,
primary endpoint), 50 percent (ACR50) and 70 percent (ACR70)
responses, low disease activity (defined as DAS28(CRP) ≤ 3.2) and
clinical remission (defined as DAS28(CRP) < 2.6) at Weeks 12 and
24.
Additional FINCH 2 data to be presented include positive results
across several patient-reported health-related quality of life
measures. Patients receiving filgotinib 100mg or 200mg once-daily
experienced greater reduction in the Health Assessment
Questionnaire Disability Index (HAQ-DI) at Week 12 compared with
those receiving placebo (-0.46 and -0.50 vs -0.19; both
p<0.001). Patients receiving filgotinib 100mg or 200mg also
experienced greater improvements on the Short-Form Health Survey
(SF-36) Physical Component Score (PCS) at Week 12 (7.6 and 8.4 vs
4.2; both p<0.001) and on the Functional Assessment of Chronic
Illness Therapy-Fatigue Scale (FACIT-Fatigue) at Week 12 (8.4 and
10.2 vs 5.2; p=0.007 and p<0.001) compared with patients
receiving placebo.
Filgotinib demonstrated a safety profile consistent with earlier
clinical trials. Rates of serious treatment-emergent adverse events
were similar for the filgotinib 100mg, 200mg and placebo groups
(5.2 percent, 4.1 percent and 3.4 percent, respectively). The
proportion of patients who discontinued study drug due to
treatment-emergent adverse events was also similar across groups.
Serious infections occurred at similar rates across the three study
arms (2.0 percent, 0.7 percent and 1.4 percent, respectively). A
total of four cases of uncomplicated Herpes zoster occurred in the
filgotinib arms, and one non-serious case of retinal vein occlusion
was reported in the filgotinib 200 mg group. Two major adverse
cardiovascular events were reported, one in the filgotinib 100mg
group and one in the placebo group. No deaths occurred during the
study.
“Inflammatory diseases are an important area of focus for
Gilead’s research and development and filgotinib is a cornerstone
of this work,” said John McHutchison, AO, MD, Chief Scientific
Officer and Head of Research and Development, Gilead Sciences. “The
results of FINCH 2 add further support to the potential role of
filgotinib in treating patients with rheumatoid arthritis.”
“For many people living with rheumatoid arthritis, the effects
of pain, inflammation and fatigue can take a serious toll in their
everyday lives. We are encouraged by these data, which suggest
filgotinib can improve symptoms of rheumatoid arthritis in patients
who have not responded to prior biologic treatment and who need new
therapies that are safe and effective,” said Dr. Walid Abi-Saab,
Chief Medical Officer at Galapagos. “We are committed to developing
filgotinib to address the unmet needs of these patients.”
Filgotinib is an investigational compound and is not approved
anywhere globally. Its efficacy and safety have not been
established. For information about the clinical trials with
filgotinib: www.clinicaltrials.gov.
About the FINCH 2 Trial
FINCH 2 was a global, 24-week, randomized, double-blind,
placebo-controlled, Phase 3 study evaluating daily oral filgotinib
on a background of conventional synthetic disease-modifying
anti-rheumatic drug(s) (csDMARDs) in adult patients with
moderately-to-severely active rheumatoid arthritis who had not
adequately responded (or were intolerant) to prior biologic DMARDs
(bDMARDs). In this study, 23.4 percent of patients had received
three or more bDMARDs. Patients were randomized (1:1:1) to receive
filgotinib 100 mg, filgotinib 200 mg or placebo. The primary
endpoint was the proportion of patients achieving an ACR20 response
at Week 12. Treatment-emergent adverse events are those reported
during the study or within 30 days of the last dose of study
drug.
For information about clinical trials with filgotinib:
www.clinicaltrials.gov.
About the Galapagos – Gilead
Collaboration
Galapagos and Gilead entered into a global collaboration for the
development and commercialization of filgotinib in inflammatory
indications. Ongoing clinical studies include the FINCH Phase 3
program in rheumatoid arthritis, the DIVERSITY Phase 3 trial in
Crohn’s disease, the Phase 2b/3 SELECTION trial in ulcerative
colitis and Phase 2 studies in small bowel and fistulizing Crohn’s
disease, psoriatic arthritis, ankylosing spondylitis, Sjogren’s
syndrome, lupus and uveitis.
About Galapagos
Galapagos (Euronext & NASDAQ: GLPG) is a clinical-stage
biotechnology company specialized in the discovery and development
of small molecule medicines with novel modes of action. Galapagos’
pipeline comprises Phase 3 through to discovery programs in
inflammation, fibrosis, cystic fibrosis, osteoarthritis and other
indications. Our target discovery platform has delivered three
novel mechanisms showing promising patient results in,
respectively, inflammatory diseases, idiopathic pulmonary fibrosis
and atopic dermatitis. Our ambition is to become a leading global
biopharmaceutical company, focused on the development and
commercialization of innovative medicines that will improve
people’s lives. The Galapagos group, including fee-for-service
subsidiary Fidelta, has approximately 675 employees, operating from
its Mechelen, Belgium headquarters and facilities in the
Netherlands, France, Switzerland, the US and Croatia. More
information at www.glpg.com.
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.
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, 2018, 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.
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Galapagos
ContactsInvestors:Elizabeth Goodwin,
+1-781-460-1784VP IR & Corporate Communicationsir@glpg.comSofie
Van Gijsel, +32 485 191415Director
IRir@glpg.comorMedia:Evelyn Fox, +31 6 53 591 999Director
Communicationscommunications@glpg.comorGilead ContactsInvestors:Sung Lee,
+1 650-524-7792orMedia:Nathan Kaiser, +1 650-522-1853
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