-- Pooled Analysis from the FINCH RA Clinical Program
with Investigational Filgotinib Reinforces Favorable Safety and
Tolerability Profile Alone and in Combination with Methotrexate
(MTX) or Conventional Disease Modifying Antirheumatic Drug(s)
(csDMARDs) --
-- Data Demonstrate Efficacy and Safety Across a Wide Range
of Patient Populations, Including Those Intolerant or Unresponsive
to Biologic Treatment --
-- Data to be Presented at 2019 ACR/ARP
Annual Meeting --
Foster City, Calif., and Mechelen, Belgium,
November 9, 2019, 22.30 CET – Gilead Sciences, Inc. (Nasdaq:
GILD) and Galapagos NV (Euronext & NASDAQ: GLPG) today
announced detailed results from the companies’ clinical research
program evaluating filgotinib, an investigational, oral, selective
JAK1 inhibitor, in adults with moderately-to-severely active RA.
The data demonstrate durable efficacy and safety results with
filgotinib across multiple RA patient populations, from MTX-naïve
patients to those who have had an inadequate response to two or
more biologic disease-modifying anti-rheumatic drugs (bDMARDs). The
analyses will be presented at the 2019 American College of
Rheumatology/Association of Rheumatology Professionals (ACR/ARP)
Annual Meeting in Atlanta.
“These new analyses continue to demonstrate the
consistent efficacy and safety profile of filgotinib for a broad
range of patients, including those who have already tried other
treatments and require other effective and tolerable options,” said
John Sundy, MD, PhD, Senior Vice President, Inflammation and
Respiratory Diseases, Gilead Sciences. “With the presentation of
these results at ACR, we are one step closer in our journey to
deliver upon the promise of filgotinib for patients in need.”
“People living with RA often struggle with
debilitating, long-term symptoms that can negatively impact their
quality of life,” said Dr. Walid Abi-Saab, Chief Medical Officer at
Galapagos. “These latest analyses continue to support the clinical
potential of filgotinib in RA patients whose disease activity may
not be adequately controlled by current treatments.”
Efficacy Sustained in Difficult-to-Treat RA
Populations
Abstract #517A subgroup analysis from the Phase
3 FINCH 2 trial evaluating once-daily doses of filgotinib 200 mg
and 100 mg with stable dose of csDMARDs in 449 patients who
previously had an inadequate response to biologic DMARD therapy
(bDMARD-IR) showed that both doses of filgotinib improved clinical
outcomes versus placebo, regardless of the number and mechanism of
action (MOA) of prior bDMARD or IL-6 inhibitor use. The proportion
of patients in the filgotinib 200 mg and 100 mg groups treated with
more than one bDMARD, who achieved ACR20 at week 12 was 70.3
percent and 58.2 percent, respectively versus placebo (25.7
percent). Additionally, 68 percent of bDMARD-IR patients in the
filgotinib 200 mg group and 51.2 percent of bDMARD-IR patients in
the 100 mg group who had been treated with more than one biologic
MOA achieved ACR20 response versus placebo (27.3 percent).
Abstract #504A separate analysis of the FINCH 2
trial assessed the efficacy of once-daily filgotinib 200 mg or 100
mg versus placebo for 24 weeks across prespecified subgroup
characteristics such as disease duration/activity, seropositivity
and concurrent medication use. Filgotinib efficacy was measured by
ACR20, and Disease Activity Score 28 (DAS28(CRP)) ≤3.2 and
DAS28(CRP) < 2.6. Results demonstrate that, compared with
placebo, filgotinib consistently improved clinical outcomes in
bDMARD-IR patients and that treatment efficacy was not impacted by
any of these demographic and clinical baseline characteristics.
Latest Analyses Demonstrate Consistent Safety
Profile
Abstract #1329The safety and tolerability of
filgotinib as a monotherapy and in combination with MTX or csDMARDs
were found to be favorable in a pooled safety analysis across the
randomized, multicenter Phase 3 FINCH 1, 2 and 3 studies at both
the 200 mg and 100 mg doses. The pooled analysis assessed a total
of 3,452 patients with moderately to severely active RA who had an
inadequate response to MTX (FINCH 1), who were receiving csDMARDs
and had an inadequate response to bDMARDs (FINCH 2) or who were
MTX-naïve (FINCH 3).
Pooled safety results across groups indicate
that the frequency of adjudicated positive major adverse cardiac
events (MACE), herpes zoster virus, deep vein thrombosis (DVT) and
pulmonary embolism (PE) was low for patients treated with
filgotinib as monotherapy, as well as in combination with MTX or
csDMARDs. The incidences of adjudicated positive MACE were 0.2
percent in both the filgotinib 200 and 100 mg treatment groups, as
well as 0.3 and 0.5 percent for adalimumab and placebo plus MTX or
csDMARDs, respectively. Additionally, the incidences of DVT/PE were
less than 0.1 percent in the 200 mg monotherapy, filgotinib 100 mg
and 200 mg plus MTX or csDMARD treatment groups, as well as 0
percent in the adalimumab treatment group and 0.3 percent of those
in the placebo plus MTX or csDMARDs treatment group. Two patient
deaths were reported in the placebo plus MTX/csDMARD treatment
group, and 4 total patient deaths were reported across the
filgotinib 200 mg and 100 mg plus MTX/csDMARD combination groups.
The treatment-emergent adverse events (TEAEs) of interest
were also similar across groups, and the most common TEAEs were
infections.
Abstract #2875A separate analysis from the FINCH
2 trial assessed shifts from baseline at 12 and 24 weeks in
hemoglobin, platelets, neutrophils and lymphocytes which all
remained consistent throughout the study. At baseline, 129 (28.8
percent), 4 (0.9 percent), 10 (2.2 percent) and 26 (5.8 percent)
patients had mild-moderate low levels of hemoglobin, platelet,
neutrophil and lymphocyte, respectively, and 5 (1.1 percent) had
severely low levels of lymphocytes. Of the 129 patients with
mild-moderate low hemoglobin at baseline, 27 of 82 patients in the
filgotinib treatment groups shifted towards hemoglobin
normalization at week 12, with similar patterns of improvement from
baseline observed for platelet, lymphocyte and neutrophil counts.
These results suggest that filgotinib, which selectively inhibits
JAK1, may not increase the incidence of anemia, thrombocytopenia or
leukopenia.
Long-Term Safety and Efficacy of
Filgotinib Abstract #550
Data comprising 2,203 patient-years of exposure
(PYE) with filgotinib from the Phase 2b, open-label extension
DARWIN 3 study assessed the long-term safety and efficacy of
filgotinib (200 mg or 100 mg) monotherapy and filgotinib plus MTX
in 739 patients. An observed case analysis at 156 weeks found that
89.7 percent of patients in the filgotinib monotherapy group and
87.2 percent of patients in the filgotinib plus MTX group were in
an ACR20 response state. TEAEs occurred in 83.9 percent (n=203) of
the filgotinib monotherapy group and in 84.3 percent (n=419) of the
filgotinib plus MTX group. Serious TEAEs occurred in 13.6 percent
(n=33) of the filgotinib monotherapy group and 9.1 percent (n=45)
of the filgotinib plus MTX group. Rates of herpes zoster in the
filgotinib monotherapy group and filgotinib plus MTX groups were
1.6 and 1.5 events per 100 PYE, respectively. Additionally, event
rates of serious infection across these treatment groups were 0.9
and 2.0 per 100 PYE. These results indicate that filgotinib
efficacy could be sustained through 156 weeks of treatment for some
patients in both monotherapy and MTX combination use. No new safety
signals were observed.
Filgotinib is an investigational agent and is
not approved by the U.S. Food and Drug Administration, European
Medicines Agency, or any other regulatory authority. Its efficacy
and safety have not been established. For information about the
clinical trials with filgotinib: www.clinicaltrials.gov.
About the FINCH Programi
The FINCH Phase 3 program investigated the
efficacy and safety of 100 mg and 200 mg filgotinib once daily, in
RA patient populations ranging from methotrexate-naïve (MTX) to
biologic-experienced patients. FINCH 1 was a 52‑week, randomized,
placebo- and adalimumab-controlled trial in combination with MTX
enrolling 1,759 adult patients with moderately to severely active
RA who had inadequate response to MTX. The primary endpoint was
ACR20 at week 12. The trial included radiographic assessment at
weeks 12, 24 and 52. FINCH 2 was a 24-week, randomized,
placebo-controlled trial in 449 patients who were receiving
conventional disease-modifying anti-rheumatic drugs (cDMARD), and
had a prior inadequate response to one or more biological
therapies. The primary endpoint was ACR20 at week 12. FINCH 3 was a
52‑week, randomized trial in 1,252 MTX-naïve patients to evaluate
filgotinib 200 mg alone and filgotinib 100 mg or 200 mg combined
with MTX versus MTX alone in MTX-naïve patients. The primary
endpoint was ACR20 at week 24. Radiographic progression was also
assessed at week 24 and 52 in FINCH 3.
About the DARWIN Programii
DARWIN 3 is an ongoing multi-center, open-label,
long-term extension study of the double-blind, placebo-controlled
DARWIN 1 and DARWIN 2 Phase 2b trials in patients with moderate to
severe RA who showed an inadequate response to methotrexate. DARWIN
1 (594 patients) evaluated filgotinib plus methotrexate, with
either once- or twice-daily administration and at three daily dose
levels. DARWIN 2 (283 patients) evaluated filgotinib as once-daily
monotherapy at three dose levels. Both DARWIN 1 and DARWIN 2
achieved the primary endpoints (ACR20). The most common AEs noted
in the studies were herpes zoster, infections and malignancy
excluding non-melanoma skin cancer.
About the Filgotinib Collaborationiii
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 in Crohn’s
disease (also small bowel and fistulizing Crohn’s disease Phase 2
studies), the Phase 3 SELECTION trial in ulcerative colitis and the
Phase 3 PENGUIN 1 and PENGUIN 2 trials in psoriatic arthritis.
More information about clinical trials with
filgotinib can be accessed at: www.clinicaltrials.gov.
About GalapagosGalapagos (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.
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 may be unable to complete one or more
of such trials in the currently anticipated timelines or at all.
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
September 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.
For more information on Gilead Sciences,
please visit the company’s website at www.gilead.com, follow
Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs
at 1-800-GILEAD-5 or 1-650-574-3000.
i FINCH Clinical Program Trial Details: FINCH 1 (NCT02889796);
FINCH 2 (NCT02873936); FINCH 3 (NCT02886728)
ii DARWIN Clinical Program Trial Details: DARWIN 3
(NCT02065700); DARWIN 2 (NCT01894516); DARWIN 1 (NCT01888874)
iii Gilead & Galapagos Filgotinib Clinical Program Trial
Details: EQUATOR (NCT03320876); TORTUGA (NCT03117270); DIVERSITY
(NCT02914561); SELECTION (NCT02914522); PENGUIN 1 (NCT04115748);
PENGUIN 2 (NCT04115839)
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