-- Filgotinib 100 mg and 200 mg Doses Achieved Significantly
Higher ACR20/50/70 Responses than Placebo in Patients with Active
Rheumatoid Arthritis and Prior Inadequate Response to Biologic Agents --
-- Both Filgotinib Doses also Achieved All Key Secondary Efficacy
Endpoints, including Low Disease Activity and Clinical Remission --
-- Tolerability of Filgotinib was Consistent with Previously
Reported Studies --
Company Website:
http://www.gilead.com
FOSTER CITY, Calif. & MECHELEN, Belgium -- (Business Wire)
Gilead Sciences, Inc. (NASDAQ: GILD) and Galapagos NV (Euronext &
NASDAQ: GLPG) today announced that FINCH 2, a global, randomized,
placebo-controlled, Phase 3 study of filgotinib, an investigational,
selective JAK1 inhibitor, in adults with moderately-to-severely active
rheumatoid arthritis and prior inadequate response/intolerance to
biologic agents, achieved its primary endpoint in the proportion of
patients achieving an American College of Rheumatology 20 percent
response (ACR20) at Week 12. Also at Weeks 12 and 24, the proportion of
patients achieving ACR50 and ACR70, low disease activity (LDA,
DAS28(CRP) ≤ 3.2), and clinical remission (DAS28(CRP) < 2.6) were
significantly higher for patients receiving once-daily filgotinib 100 mg
or 200 mg compared to patients receiving placebo.
Top-line efficacy data are summarized in the table below.
Non-responder imputation
|
|
Week 12
|
|
Week 24
|
|
Placebo (n=148)# |
|
Filgotinib 100 mg (n=153) # |
|
Filgotinib 200 mg (n=147) # |
|
Placebo (n=148) # |
|
Filgotinib 100 mg (n=153) # |
|
Filgotinib 200 mg (n=147) # |
ACR20 (%)
|
|
31.1
|
|
57.5***
|
|
66.0***
|
|
34.5
|
|
54.9***
|
|
69.4***
|
ACR50 (%)
|
|
14.9
|
|
32.0***
|
|
42.9***
|
|
18.9
|
|
35.3**
|
|
45.6***
|
ACR70 (%)
|
|
6.8
|
|
14.4*
|
|
21.8***
|
|
8.1
|
|
20.3**
|
|
32.0***
|
DAS28(CRP) ≤ 3.2 (Low disease activity) (%)
|
|
15.5
|
|
37.3***
|
|
40.8***
|
|
20.9
|
|
37.9**
|
|
48.3***
|
DAS28(CRP) < 2.6 (Clinical remission) (%)
|
|
8.1
|
|
25.5***
|
|
22.4***
|
|
12.2
|
|
26.1**
|
|
30.6***
|
#Number of patients randomized to each treatment group
and who received at least one dose of study drug
|
ACR20/50/70 represents American College of Rheumatology
20%/50%/70% improvements.
|
* p <0.05, compared to placebo
|
** p <0.01, compared to placebo
|
*** p <0.001, compared to placebo
|
|
Filgotinib was generally well-tolerated in the FINCH 2 trial, with no
new safety signals compared to those reported in previous trials of
filgotinib. Treatment-emergent adverse events and serious adverse events
were mostly mild or moderate in severity. Serious adverse events
occurred in 3.4, 5.2 and 4.1 percent of the patients in the placebo,
100mg and 200mg groups, respectively. The proportion of patients who
discontinued study drug due to treatment-emergent adverse events was
also similar across groups. Two cases of uncomplicated herpes zoster
were reported in each filgotinib group. Two major adverse cardiovascular
events (MACE) were identified, one subarachnoid hemorrhage in the
placebo group and one myocardial ischemia in the filgotinib 100 mg
group. There was one case of non-serious retinal vein occlusion in the
filgotinib 200 mg group and no reports of deep venous thrombosis (DVT)
or pulmonary embolism (PE). There were no deaths, malignancies,
gastrointestinal perforations, or opportunistic infections, including
active tuberculosis.
Detailed findings from the FINCH 2 study will be submitted for
presentation at a future scientific conference.
“Gilead is committed to the development of new therapies that offer
meaningful benefit for people living with rheumatoid arthritis and other
serious inflammatory diseases,” said John McHutchison, MD, Chief
Scientific Officer, Head of Research and Development, Gilead Sciences.
“These initial Phase 3 data support the potential of filgotinib, in
combination with select disease modifying drugs, to help patients with
active rheumatoid arthritis who do not adequately respond to current
biologic disease modifying agents. These data are particularly
encouraging as we look ahead to Phase 3 results from the ongoing FINCH 1
and 3 trials, which are exploring filgotinib in other populations of
patients with rheumatoid arthritis.”
“We are pleased that filgotinib has demonstrated significantly improved
clinical responses in this difficult to treat population,” said
Dr. Walid Abi-Saab, Chief Medical Officer at Galapagos. “The good
tolerability in this study is also very encouraging.”
Filgotinib is investigational and not approved anywhere globally. Its
efficacy and safety have not been established. For information about the
clinical trials with filgotinib: www.clinicaltrials.gov.
About FINCH 2
FINCH 2 was a global, 24-week randomized, double-blind,
placebo-controlled, Phase 3 study evaluating filgotinib on a background
of conventional synthetic disease-modifying anti-rheumatic drug(s)
(csDMARDs) among adult patients with moderately-to-severely active
rheumatoid arthritis who had not adequately responded to biologic DMARDs
(bDMARDs). In this study, 23.7 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.
Protocol-defined non-responders at Week 14 were allowed to complete the
trial under standard of care therapy. Treatment-emergent adverse events
are those reported during treatment 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. Along with FINCH 1 and 3, the Phase 3 FINCH 2 trial is one
of several clinical trials of filgotinib in rheumatoid arthritis or
other inflammatory diseases, including the EQUATOR Phase 2 program in
psoriatic arthritis, the TORTUGA study in ankylosing spondylitis, the
DIVERSITY Phase 3 trial in Crohn’s disease (also small bowel and
fistulizing Crohn’s disease Phase 2 studies) and the Phase 3 SELECTION
trial in ulcerative colitis.
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 cystic fibrosis, inflammation,
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. Galapagos is focused on the development
and commercialization of novel 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 Statements
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.
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. 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20180911005700/en/
Contacts:
Galapagos Contacts
Investors:
Elizabeth
Goodwin, +1-781-460-1784
VP IR & Corporate Communications
ir@glpg.com
or
Paul
van der Horst, +31 71 750 6707
Director IR & Business Development
ir@glpg.com
or
Media:
Evelyn
Fox, +31 6 53 591 999
Director Communications
communications@glpg.com
or
Gilead
Contacts
Investors:
Sung Lee, +1 650-524-7792
or
Media:
Nathan
Kaiser, +1 650-522-1853
Source: Gilead Sciences, Inc.
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