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-- Phase 3 FINCH 1 and FINCH 3 Data of Filgotinib in Rheumatoid Arthritis to Be Featured in Opening Plenary and Late Breaker Sessions --
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“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
“This meeting marks our first opportunity to present the results from
the FINCH 1 and 3 filgotinib trials in rheumatoid arthritis,” said Dr.
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
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
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
About
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’
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
View source version on businesswire.com: https://www.businesswire.com/news/home/20190529005911/en/
Source:
Galapagos ContactsInvestors:Elizabeth GoodwinVP IR+1-781-460-1784
Sofie Van GijselDirector IR+32 485 19 14 15ir@glpg.com
Media:Carmen VroonenSenior Director Communications+32 473 824 874
Evelyn FoxDirector Communications+31 6 53 591 999communications@glpg.com
Gilead ContactsInvestors:Sung Lee+1 650-524-7792
Media:Arran Attridge+1 650-425-8975
Investors
Jacquie Ross
investors_relations@gilead.com
Media Contact
Meaghan Smith
public_affairs@gilead.com
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