— Filgotinib 100 mg and 200 mg Plus Methotrexate (MTX)
Demonstrated Significantly Higher ACR20/50/70 Responses Than
Methotrexate Alone —
— Filgotinib Safety Profile Consistent With Previously Reported
Results —
FOSTER CITY, Calif. and MECHELEN, Belgium–(BUSINESS WIRE)–regulated information – Gilead Sciences, Inc. (NASDAQ: GILD)
and Galapagos NV (Euronext & NASDAQ: GLPG) today announced Week 24
results of FINCH 3, an ongoing, randomized, double-blind,
active-controlled Phase 3 study of filgotinib, an investigational, oral,
selective JAK1 inhibitor, in adults with moderately-to-severely active
rheumatoid arthritis. FINCH 3 evaluated filgotinib in combination with
methotrexate and as monotherapy in MTX-naïve patients. The study
achieved its primary endpoint in the proportion of patients achieving an
American College of Rheumatology 20 percent response (ACR20) at Week 24.
The proportion of patients achieving the primary endpoint of ACR20
response at Week 24 was significantly higher for filgotinib 200 mg plus
MTX and filgotinib 100 mg plus MTX compared with MTX alone.
The proportion of patients achieving ACR50, ACR70, and clinical
remission (DAS28(CRP) < 2.6) at Week 24 was also significantly higher
for patients receiving once-daily filgotinib 100 mg or 200 mg plus MTX
compared with patients receiving MTX alone. Additionally, those who
received filgotinib experienced greater reduction in the Health
Assessment Questionnaire Disability Index (HAQ-DI) compared with those
receiving MTX alone at Week 24. Filgotinib 200 mg monotherapy inhibited
the progression of structural damage at Week 24 compared with MTX alone
as assessed by modified total Sharp score (mTSS).
Top-line FINCH 3 efficacy† data are summarized in the table
below:
|
Filgotinib 200 mg |
Filgotinib 100 mg |
Filgotinib 200 mg |
MTX |
|||||
| ACR20 (%) | 81.0*** | 80.2* | 78.1 | 71.4 | ||||
| ACR50 (%) | 61.5*** | 57.0** | 58.1**# | 45.7 | ||||
| ACR70 (%) | 43.8*** | 40.1*** | 40.0***# | 26.0 | ||||
| DAS28(CRP) < 2.6 (Clinical remission) (%) | 54.1*** | 42.5*** | 42.4***# | 29.1 | ||||
| HAQ-DI change | -0.94*** | -0.90** | -0.89*# | -0.79 | ||||
| mTSS change | 0.20 | 0.22 | -0.04**# | 0.52 |
†Efficacy assessed at Week 24 for all endpoints
&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 <0.001, compared with
MTX
* p < 0.05, compared with MTX
** p <0.01, compared with
MTX
# Comparison not adjusted for multiplicity
The safety profile of filgotinib in FINCH 3 is consistent with prior
studies up to Week 24. Serious adverse events occurred in 4.1 percent,
2.4 percent, 4.8 percent, and 2.9 percent of patients receiving
filgotinib 200 mg plus MTX, filgotinib 100 mg plus MTX, filgotinib 200
mg monotherapy and MTX alone, respectively. There was one venous
thrombotic event (in the MTX group), five cases of adjudicated major
adverse cardiovascular events (two in the filgotinib 200 mg plus MTX
group, one in the filgotinib 200 mg group and two in the MTX group) and
one malignancy (in the MTX group). There was one death, reported in the
filgotinib 200 mg plus MTX group. Serious infections occurred in 1.0
percent, 1.0 percent, 1.4 percent and 1.0 percent of the patients in the
filgotinib 200 mg plus MTX, filgotinib 100 mg plus MTX, filgotinib 200
mg monotherapy and MTX groups, respectively. The proportion of patients
reporting herpes zoster was 0.5 percent in each of the treatment groups.
“The FINCH 3 data clearly demonstrate improved efficacy when filgotinib
is compared with the use of MTX alone in rheumatoid arthritis patients
with earlier stages of disease,” said John McHutchison, AO, MD, Chief
Scientific Officer, Head of Research and Development, Gilead Sciences.
“These data add to the body of evidence from our broader FINCH clinical
study program, reinforcing the potential for filgotinib to address
important therapeutic needs in people with rheumatoid arthritis.”
“Additional effective and tolerable treatment options are still needed
for people newly diagnosed with rheumatoid arthritis or in the early
stages of the disease. This complements the FINCH 1 and FINCH 2 data,
underlining the potential of filgotinib as a treatment option across a
wide range of patient populations suffering from rheumatoid arthritis.”
said Dr. Walid Abi-Saab, Chief Medical Officer, Galapagos.
Detailed findings from FINCH 3 will be submitted for presentation at a
future scientific conference. Filgotinib is an investigational agent and
not approved anywhere globally. Its efficacy and safety have not been
established.
About FINCH 3
FINCH 3 is an ongoing 52-week randomized, double-blind and
active-controlled study examining filgotinib alone and in combination
with MTX, enrolling 1,252 adult patients with moderately to severely
active RA who are naïve to MTX. Patients were randomized (2:1:1:2) to
receive filgotinib 200 mg plus MTX (n=417), filgotinib 100 mg plus MTX
(n=207), filgotinib 200 mg alone (n=210) or MTX (n=418). The primary
endpoint is the proportion of patients who achieve an ACR20 response at
Week 24.
More information about clinical trials with filgotinib can be accessed
at: 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. The FINCH studies are among several clinical trials of
filgotinib in 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) 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 Phase 3 through to discovery
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.
This press release contains inside information within the meaning of
Regulation (EU) No 596/2014 of the European Parliament and of the
Council of 16 April 2014 on market abuse (market abuse regulation).
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 Annual Report
on Form 10-K for the year ended December 31, 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.
Contacts
Galapagos Contacts
Investors:
Elizabeth
Goodwin
VP IR
+1-781-460-1784
Sofie Van Gijsel
Director
IR
+32 485 19 14 15
ir@glpg.com
Media:
Carmen
Vroonen
Senior Director Communications
+32 473 824 874
Evelyn
Fox
Director Communications
+31 6 53 591 999
communications@glpg.com
Gilead
Contacts
Investors:
Sung Lee
+1
650-524-7792
Media:
Nathan Kaiser
+1
650-522-1853