September 11, 2018
Gilead and Galapagos Announce Filgotinib Meets Primary and All Key Secondary Endpoints in First Phase 3 Study in Rheumatoid Arthritis
-- Filgotinib 100 mg and 200 mg Doses Achieved Significantly Higher ACR20/50/70 Responses than Placebo in Patients with Active Rheumatoid Arthritis and Prior Inadequate Response to Biologic Agents --
-- Both Filgotinib Doses also Achieved All Key Secondary Efficacy Endpoints, including Low Disease Activity and Clinical Remission --
-- Tolerability of Filgotinib was Consistent with Previously Reported Studies --
Top-line efficacy data are summarized in the table below.
|Week 12||Week 24|
|DAS28(CRP) ≤ 3.2 (Low disease activity) (%)||15.5||37.3***||40.8***||20.9||37.9**||48.3***|
|DAS28(CRP) < 2.6 (Clinical remission) (%)||8.1||25.5***||22.4***||12.2||26.1**||30.6***|
#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 <0.05, compared to placebo|
|** p <0.01, compared to placebo|
|*** p <0.001, compared to placebo|
Filgotinib was generally well-tolerated in the FINCH 2 trial, with no new safety signals compared to those reported in previous trials of filgotinib. Treatment-emergent adverse events and serious adverse events were mostly mild or moderate in severity. Serious adverse events occurred in 3.4, 5.2 and 4.1 percent of the patients in the placebo, 100mg and 200mg groups, respectively. The proportion of patients who discontinued study drug due to treatment-emergent adverse events was also similar across groups. Two cases of uncomplicated herpes zoster were reported in each filgotinib group. Two major adverse cardiovascular events (MACE) were identified, one subarachnoid hemorrhage in the placebo group and one myocardial ischemia in the filgotinib 100 mg group. There was one case of non-serious retinal vein occlusion in the filgotinib 200 mg group and no reports of deep venous thrombosis (DVT) or pulmonary embolism (PE). There were no deaths, malignancies, gastrointestinal perforations, or opportunistic infections, including active tuberculosis.
Detailed findings from the FINCH 2 study will be submitted for presentation at a future scientific conference.
“Gilead is committed to the development of new therapies that offer
meaningful benefit for people living with rheumatoid arthritis and other
serious inflammatory diseases,” said
“We are pleased that filgotinib has demonstrated significantly improved clinical responses in this difficult to treat population,” said Dr. Walid Abi-Saab, Chief Medical Officer at Galapagos. “The good tolerability in this study is also very encouraging.”
Filgotinib is investigational and not approved anywhere globally. Its efficacy and safety have not been established. For information about the clinical trials with filgotinib: www.clinicaltrials.gov.
About FINCH 2
FINCH 2 was a global, 24-week randomized, double-blind, placebo-controlled, Phase 3 study evaluating filgotinib on a background of conventional synthetic disease-modifying anti-rheumatic drug(s) (csDMARDs) among adult patients with moderately-to-severely active rheumatoid arthritis who had not adequately responded to biologic DMARDs (bDMARDs). In this study, 23.7 percent of patients had received three or more bDMARDs. Patients were randomized (1:1:1) to receive filgotinib 100 mg, filgotinib 200 mg or placebo. The primary endpoint was the proportion of patients achieving an ACR20 response at week 12. Protocol-defined non-responders at Week 14 were allowed to complete the trial under standard of care therapy. Treatment-emergent adverse events are those reported during treatment or within 30 days of the last dose of study drug.
For information about clinical trials with filgotinib: 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. Along with FINCH 1 and 3, the Phase 3 FINCH 2 trial is one of several clinical trials of filgotinib in rheumatoid arthritis or other 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.
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
Elizabeth Goodwin, +1-781-460-1784
VP IR & Corporate Communications
Paul van der Horst, +31 71 750 6707
Director IR & Business Development
Evelyn Fox, +31 6 53 591 999
Sung Lee, +1 650-524-7792
Nathan Kaiser, +1 650-522-1853