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Gilead and Galapagos Announce Filgotinib Meets Primary and Key Secondary Endpoints in the Phase 3 FINCH 1 Rheumatoid Arthritis Study

March 28, 2019 Off By BusinessWire

— Filgotinib 100 mg and 200 mg Doses Demonstrated Significantly
Higher ACR20/50/70 Responses than Placebo in Patients with Prior
Inadequate Methotrexate Response —

— Significant Inhibition of Radiographic Progression Demonstrated
with Both Doses of Filgotinib versus Placebo —

— Safety Profile of Filgotinib Consistent with Previously
Reported Results —

FOSTER CITY, Calif. & MECHELEN, Belgium–(BUSINESS WIRE)–regulated information – Gilead Sciences, Inc. (NASDAQ: GILD)
and Galapagos NV (Euronext & NASDAQ: GLPG) today announced Week 24
results of FINCH 1, an ongoing, randomized, double-blind, placebo- and
active-controlled Phase 3 study of filgotinib, an investigational, oral,
selective JAK1 inhibitor, in adults with moderately-to-severely active
rheumatoid arthritis. FINCH 1 evaluated filgotinib versus adalimumab or
placebo, on a stable background dose of methotrexate in patients with
prior inadequate response to methotrexate. The study achieved its
primary endpoint for both doses of filgotinib in the proportion of
patients achieving an American College of Rheumatology 20 percent
response (ACR20) compared to placebo at Week 12.

The proportion of patients achieving ACR50 and ACR70 response was also
significantly greater for filgotinib compared with placebo at Week 12,
for both doses. Patients receiving filgotinib 100 mg or 200 mg had a
statistically significant reduction in the Health Assessment
Questionnaire Disability Index (HAQ-DI) at Week 12 compared with those
receiving placebo. The proportions of patients achieving clinical
remission (DAS28(CRP) < 2.6) and low disease activity (DAS28(CRP) ≤ 3.2)
at Week 12 were significantly higher for patients in both filgotinib
arms compared with placebo. When comparing low disease activity rates at
Week 12, filgotinib 200 mg was non-inferior to adalimumab. Filgotinib
100 mg and 200 mg also significantly inhibited the progression of
structural damage at Week 24 as assessed by change from baseline in
modified total Sharp score (mTSS) compared with placebo.

Top-line FINCH 1 efficacy^† data are summarized in the table
below.

Filgotinib
200 mg
+MTX

(n=475)^&

Filgotinib
100 mg
+MTX

(n=480)^&

Adalimumab 40 mg
+MTX

(n=325)^&

Placebo
+MTX

(n=475)^&

ACR20 (%)

76.6***

69.8***

70.8

49.9

ACR50 (%)

47.2***

36.3***

35.1

19.8

ACR70 (%)

26.3***

18.5***

14.2

6.7

DAS28(CRP) ≤ 3.2
(Low disease activity) (%)

49.7***^$

38.8***

43.4

23.4

DAS28(CRP) < 2.6
(Clinical remission) (%)

33.9*** ^¥#

23.8*** ^£#

23.7

9.3

HAQ-DI change

-0.69***

-0.56***

-0.61

-0.42

mTSS change

0.13^***

0.17^***

0.16

0.38

^†All efficacy time points assessed at Week 12 except mTSS
which was assessed at Week 24

^&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 placebo

^$ p <0.001, non-inferiority to adalimumab

^£ p <0.01, non-inferiority to adalimumab

^¥ p <0.01, superiority to adalimumab

^# Comparison not adjusted for multiplicity

The safety profile of filgotinib in FINCH 1 is consistent with prior
studies up to Week 24. Serious adverse events occurred in 4.4 percent,
5.0 percent, 4.3 percent and 4.2 percent of the patients in the
filgotinib 200 mg, filgotinib 100 mg, adalimumab and placebo groups,
respectively. There were five deaths, two patients were assigned to the
placebo group, two to the filgotinib 200 mg group and one to the
filgotinib 100 mg group. Five patients with a malignancy were also
reported — three receiving placebo, one receiving adalimumab and one
receiving filgotinib 100 mg, respectively. Three venous thrombotic
events were observed (two in the placebo group, one in the filgotinib
200 mg group), and there were four adjudicated major adverse
cardiovascular events, two in the placebo, one in the adalimumab and one
in the filgotinib 100 mg groups. The proportion of patients with herpes
zoster was similar across treatment groups (filgotinib 200 mg = 0.4
percent, filgotinib 100 mg = 0.4 percent, adalimumab = 0.6 percent,
placebo = 0.4 percent), as was the rate of serious infections
(filgotinib 200 mg = 1.7 percent, filgotinib 100 mg = 1.7 percent,
adalimumab = 2.5 percent, placebo = 0.8 percent).

“These FINCH 1 data add to the favorable results obtained previously in
the FINCH 2 study in patients with a prior inadequate response to
biologic agents and reinforce the evidence supporting the potential of
filgotinib to address unmet treatment needs in patients with rheumatoid
arthritis,” said John McHutchison, AO, MD, Chief Scientific Officer,
Head of Research and Development, Gilead Sciences. “Across the FINCH
program, the data continue to support filgotinib’s potential as a JAK1
specific inhibitor that may provide clinically meaningful responses
combined with a favorable safety profile in a wide range of people
living with rheumatoid arthritis, including those in the early stages of
disease and those who have tried standard therapies without success.”

“Many patients living with rheumatoid arthritis are in need of new
treatment options that are effective, well-tolerated, and convenient. We
are excited about the strong efficacy and tolerability results with both
doses of filgotinib,” said Dr. Walid Abi-Saab, Chief Medical Officer,
Galapagos. “We are particularly pleased with the results filgotinib
shows on clinically meaningful endpoints such as clinical remission,
ACR70 and radiographic progression, as well as with the encouraging
safety profile.”

Detailed findings from FINCH 1 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 1

FINCH 1 is an ongoing 52-week randomized, double-blind, placebo- and
active-controlled study, enrolling 1,759 adult patients with moderately
to severely active RA who have an inadequate response to MTX. Eligible
patients were randomized (3:3:2:3) to receive filgotinib 200 mg (n=477),
filgotinib 100 mg (n=480), adalimumab (n=325) or placebo (n=477) in
addition to a stable dose of MTX. The primary endpoint of the study is
the proportion of patients who achieve an American College of
Rheumatology 20 percent improvement response (ACR20) at Week 12. At Week
24, all patients in the placebo arm who did not discontinue study drug
were reassigned (1:1) to either filgotinib 100 mg or 200 mg.

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.