— Phase 3 FINCH 1 and FINCH 3 Data of Filgotinib in Rheumatoid
Arthritis to Be Featured in Opening Plenary and Late Breaker Sessions —
FOSTER CITY, Calif. & MECHELEN, Belgium–(BUSINESS WIRE)–Gilead Sciences, Inc. (NASDAQ: GILD) and Galapagos NV (Euronext &
NASDAQ: GLPG) today announced that data on filgotinib, an
investigational, oral, selective JAK1 inhibitor, will be presented at
the Annual European Congress of Rheumatology (EULAR 2019) in Madrid,
Spain, on June 12-15, 2019. Among the abstracts to be presented are 24
week interim results from the ongoing FINCH 1 and FINCH 3 Phase 3
studies evaluating filgotinib in adults with rheumatoid arthritis.
“These data reinforce our belief that filgotinib has the potential to
make a meaningful difference for patients with rheumatoid arthritis,
both early and also late in the course of treatment when other
treatments have failed,” said John McHutchison, AO, MD, Chief Scientific
Officer, Head of Research and Development, Gilead Sciences. “The FINCH
results reflect the growing strength and breadth of Gilead’s
inflammation pipeline and our commitment to improving the outlook for
patients living with inflammatory diseases – both with filgotinib and
our other investigational compounds.”
“This meeting marks our first opportunity to present the results from
the FINCH 1 and 3 filgotinib trials in rheumatoid arthritis,” said Dr.
Walid Abi-Saab, Chief Medical Officer, Galapagos. “These results show
the potential of filgotinib in helping to address the unmet need for
people living with this debilitating disease.”
Phase 3 Trials of Filgotinib in Rheumatoid
Arthritis
Detailed 24 week interim results from the Phase 3 FINCH 1 and 3 clinical
trials will both be presented for the first time in oral sessions at the
conference. Top-line data from these studies were announced earlier this
year. Findings from FINCH 1 will be presented in the opening plenary
session, while FINCH 3 results will be presented in the late-breaking
abstract session.
-
Efficacy and Safety of Filgotinib for Patients with Rheumatoid
Arthritis with Inadequate Response to Methotrexate: FINCH1 Primary
Outcome Results (oral #LB0001 4:25pm CET, 12 June, Hall 6) -
Efficacy and Safety of Filgotinib for Patients with Rheumatoid
Arthritis Naïve to Methotrexate Therapy: FINCH3 Primary Outcome
Results (oral #LB0003 8:00am CET, 15 June, Hall 7B)
FINCH 1 is an ongoing, randomized, double-blind, placebo- and
active-controlled Phase 3 study evaluating filgotinib versus adalimumab
or placebo in adults with moderately-to-severely active rheumatoid
arthritis on a stable background dose of methotrexate but with a prior
inadequate response to methotrexate. The study achieved its primary
endpoint at both 100 mg and 200 mg doses of filgotinib, in the
proportion of patients achieving an American College of Rheumatology
(ACR) 20 percent response (ACR20) compared with placebo at Week 12.
The proportion of patients achieving an ACR 50 percent response (ACR50)
or ACR 70 percent response (ACR70) was significantly greater for
filgotinib compared with placebo at Week 12, for both doses. The study
also achieved key secondary endpoints, including significant inhibition
of radiographic progression with both doses of filgotinib versus placebo.
FINCH 3 is an ongoing, randomized, double-blind, active-controlled Phase
3 study of filgotinib in adults with moderately-to-severely active
rheumatoid arthritis. The trial evaluated filgotinib in combination with
methotrexate and as monotherapy in methotrexate-naïve patients. The
study achieved its primary endpoint, with a significantly higher
proportion of patients reaching ACR20 in the filgotinib plus
methotrexate groups compared with patients receiving methotrexate alone.
Additionally, both doses of filgotinib demonstrated significantly higher
ACR 50 and ACR 70 responses than methotrexate alone.
In both trials, filgotinib demonstrated a safety profile consistent with
previously reported results.
Additional abstracts accepted for presentation at the meeting include:
-
Filgotinib in Patients with Rheumatoid Arthritis and Prior Inadequate
Response or Intolerance to Biologic DMARDs (bDMARD-IR) by Geographic
Region and Race (poster #THU0173) -
Selective Inhibition of Janus Kinase 1 (JAK1) by Filgotinib Modulates
the Disease-associated Whole Blood Transcriptional Profile of Patients
with Active Rheumatoid Arthritis (poster #THU0194) -
Safety and Efficacy of Filgotinib in Active Rheumatoid Arthritis by
Prior Biologic DMARD Exposure in Patients with Prior Inadequate
Response or Intolerance to Biologic DMARDs (bDMARD-IR) (poster
#FRI0092) -
Filgotinib, a Selective Janus Kinase 1 (JAK1) Inhibitor, Modulates
Disease-associated Cytokines in Patients with Active Rheumatoid
Arthritis (poster #FRI0113) -
Safety and Efficacy of Filgotinib in Patients Aged 65 Years and Older:
Results from a Phase 3 Study in Patients with Active Rheumatoid
Arthritis and Prior Inadequate Response or Intolerance to Biologic
DMARDs (bDMARD-IR) (poster #FRI0154)
Additional Data on Filgotinib in Inflammatory
Disease Management
In addition to the FINCH studies, Gilead and Galapagos will present
results from EQUATOR, a Phase 2, placebo-controlled, double-blind study
of filgotinib among patients with active psoriatic arthritis; additional
clinical data on filgotinib in individuals with hepatic impairment; and
preclinical data characterizing filgotinib among JAK inhibitors and in
combination with an ASK1 inhibitor.
-
Efficacy of Filgotinib vs. Placebo in Active Psoriatic Arthritis:
Patient-Level Data from EQUATOR, a Randomized, Phase 2 Study (oral
#OP0109) -
Filgotinib Treatment Provides Rapid and Sustained Reduction of
Inflammatory Biomarkers in Moderate to Severe Psoriatic Arthritis
(PsA) Patients (poster #THU0031) -
PsAID9 in Patients with Active Psoriatic Arthritis Treated with
Filgotinib vs Placebo: Results from EQUATOR, a Randomized, Phase 2
Study (poster #SAT0367) -
Effect of filgotinib on Patient-reported Outcomes in Active Psoriatic
Arthritis: Results from EQUATOR, a Randomized, Phase 2 Study (poster
#SAT0373) -
In Vitro Mechanistic Studies Demonstrate Filgotinib Activity that Has
Potential Implications for Differentiation among JAK Inhibitors
(poster #THU0017) -
Pharmacokinetics and Short-Term Safety of Filgotinib, a Selective
Janus Kinase 1 Inhibitor, in Subjects with Moderate Hepatic
Impairment: a Phase 1, Open-label, Single-arm Study (poster #THU0117) -
Targeting Activated ASK1 in Synovial Fibroblasts in Combination with
Jak1 Inhibition Enhances Efficacy in Rat CIA (poster #THU0014)
Filgotinib is an investigational agent and is not approved by the U.S.
Food and Drug Administration or any other regulatory authority. Its
efficacy and safety have not been established.
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.
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 March 31, 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.
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:
Arran Attridge
+1 650-425-8975