-- Filgotinib 200 mg Demonstrated Greater
Efficacy Compared with Placebo in the Induction and Maintenance of
Remission in the SELECTION Trial --
-- Rates of Adverse Events Were Low and
Comparable Across Treatment Groups --
Gilead Sciences, Inc. (Nasdaq: GILD) and Galapagos NV (Euronext
& Nasdaq: GLPG) today announced positive topline results from
SELECTION, a randomized, double-blind, placebo-controlled, Phase
2b/3 trial evaluating the efficacy and safety of the
investigational, oral, once-daily, selective JAK1 inhibitor
filgotinib in 1,348 biologic-naïve or biologic-experienced adult
patients with moderately to severely active ulcerative colitis
(UC). Filgotinib 200 mg achieved all primary endpoints in the
study, inducing clinical remission at Week 10 and maintaining
clinical remission at Week 58 in a significantly higher proportion
of patients compared with placebo. Filgotinib 100 mg did not
achieve statistically significant clinical remission at Week
10.
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In this trial, clinical remission was defined as an endoscopic
subscore of 0 or 1, rectal bleeding subscore of 0, and ≥ 1 point
decrease in stool frequency from baseline to achieve a subscore of
0 or 1. Among the biologic-naïve cohort (Cohort A induction trial;
n=659), 52 percent of patients had a baseline Mayo Clinic Score
(MCS) of nine or higher. In the biologically-experienced cohort
(Cohort B induction trial; n=689), 74 percent of patients had a
baseline MCS of nine or higher, and 51 percent were previously
treated with two different classes of biologics (TNFα antagonists
and an integrin receptor antagonist).
Among biologic-naïve patients, a statistically significant
higher proportion of patients achieved clinical remission at Week
10 when treated with filgotinib 200 mg (26.1 percent, p=0.0157)
compared with placebo (15.3 percent). Among biologic-experienced
patients, a statistically significant higher proportion of patients
achieved clinical remission at Week 10 when treated with filgotinib
200 mg (11.5 percent, p=0.0103) compared with placebo (4.2
percent).
Patients who achieved clinical response or remission after 10
weeks of treatment with filgotinib 100 mg or 200 mg were
subsequently re-randomized to their induction dose of filgotinib or
placebo in a 2:1 ratio and treated through Week 58 (maintenance
trial, n=558). Both doses of filgotinib achieved the primary
endpoint in this maintenance trial. At Week 58, 37.2 percent of
biologic-naïve and biologic-experienced patients receiving
filgotinib 200 mg achieved clinical remission, compared with 11.2
percent treated with placebo (p˂0.0001).
Of patients receiving filgotinib 100 mg, 23.8 percent achieved
clinical remission at Week 58, compared with 13.5 percent treated
with placebo (p=0.0420).
In the induction trial of biologic-naïve patients, the incidence
of serious adverse events was similar across treatment groups (200
mg: 1.2 percent; 100 mg: 4.7 percent; placebo: 2.9 percent). In the
induction trial of biologic-experienced patients, the incidence of
serious adverse events was also similar across treatment groups
(200 mg: 7.3 percent; 100 mg: 5.3 percent; placebo: 6.3 percent).
There were no deaths in either induction cohort.
In the maintenance trial, 4.5 percent of patients treated with
filgotinib 200 mg experienced a serious adverse event, compared
with none for their corresponding placebo; 4.5 percent of patients
treated with filgotinib 100 mg experienced a serious adverse event,
compared with 7.7 percent for their corresponding placebo.
Rates of serious infections, herpes zoster, venous thrombosis,
pulmonary embolism and gastrointestinal perforation were low and
comparable across treatment groups in both the induction and
maintenance phases of the study. Two deaths were observed in the
filgotinib 200 mg treatment group in the maintenance trial. One
patient with pre-existing asthma died due to asthma exacerbation,
and the second patient with pre-existing atherosclerosis died due
to left ventricular heart failure per autopsy report. Neither death
was assessed as related to study drug by the investigator.
“We are encouraged by the early response as an induction therapy
and the durable efficacy as a maintenance therapy observed in the
SELECTION trial,” said Merdad Parsey, MD, PhD, Chief Medical
Officer, Gilead Sciences. “Patients with moderate to severe
ulcerative colitis can struggle to effectively manage their
disease. These topline data suggest that filgotinib could play a
role in helping more patients achieve a meaningful and sustained
improvement in treatment response with an oral therapy.”
“We are pleased to see that SELECTION results indicate that
filgotinib can help ulcerative colitis patients, including those
refractory to treatment, achieve and sustain remission for more
than one year,” said Dr. Walid Abi-Saab, Chief Medical Officer,
Galapagos. “We believe that the results point to an efficacy and
safety profile consistent with prior studies with filgotinib, and
offer a meaningful contribution to the patient data with filgotinib
from other inflammatory conditions. We look forward to presenting
more detailed results to the scientific community.”
UC is a chronic, idiopathic inflammatory disease affecting the
colon and often involves periods of remission interspersed with
periods of active disease. Common symptoms of UC are bloody
diarrhea and rectal urgency. UC is often diagnosed in people of
working age who can face debilitating flares in their symptoms and
progression of disease overtime. An estimated 40 percent of
patients experience a relapse annuallyi and do not achieve
sustained remission.
Detailed results from the SELECTION trial will be submitted for
presentation at a future scientific conference.
Filgotinib is an investigational agent and is not approved by
the FDA or any other regulatory authority for any use. Regulatory
submissions of filgotinib for the treatment of rheumatoid arthritis
are currently under review by the FDA, European Medicines Agency,
and Japan’s Ministry of Health, Labour and Welfare. The efficacy
and safety of filgotinib have not been established. For information
about the clinical trials with filgotinib:
www.clinicaltrials.gov.
About the SELECTION Phase 2b/3
Trial
The SELECTION Phase 2b/3 trial is a multi-center, randomized,
double-blind, placebo-controlled trial to assess the safety and
efficacy of the selective JAK1 inhibitor filgotinib in adult
patients with moderately to severely active ulcerative colitis. The
SELECTION trial comprises 2 Induction Trials and a Maintenance
Trial. The Cohort A Induction Trial enrolled biologic-naive
patients, and the Cohort B Induction Trial enrolled
biologic-experienced patients.
Across both induction studies, patients with moderately to
severely active UC were randomized to receive filgotinib 200 mg,
filgotinib 100 mg or placebo in a 2:2:1 ratio. Moderately to
severely active UC was defined as a centrally read endoscopy score
≥ 2, a rectal bleeding score ≥ 1, a stool frequency score ≥ 1 and
Physician Global Assessment (PGA) of ≥ 2 based on the MCS. Patients
with clinical remission or response at Week 10 of induction were
subsequently re-randomized to the induction dose of filgotinib or
placebo in a 2:1 ratio and treated through Week 58.
The primary objectives of SELECTION are to evaluate the efficacy
of filgotinib compared with placebo in establishing EBS clinical
remission as determined by the Mayo Clinic endoscopic subscore of 0
or 1, rectal bleeding subscore of 0, and ≥ 1 point decrease in
stool frequency from baseline to achieve a subscore of 0 or 1 at
Week 10 and Week 58. Eligible patients who completed treatment in
the SELECTION trial through Week 58 were enrolled in the ongoing
SELECTION long-term extension trial to evaluate the long-term
safety of filgotinib in patients with moderately to severely active
UC.
About the Filgotinib
Collaborationii
Gilead and Galapagos NV are collaborative partners in the global
development and commercialization of filgotinib in inflammatory
indications. The SELECTION trial is one of multiple clinical
studies of filgotinib in a range of inflammatory conditions,
including the FINCH Phase 3 program in rheumatoid arthritis, the
DIVERSITY Phase 3 trial in Crohn’s disease, the Phase 3 PENGUIN
trials in psoriatic arthritis, as well as Phase 2 studies in
uveitis and in small bowel and fistulizing Crohn’s disease. More
information about clinical trials with filgotinib can be accessed
at www.clinicaltrials.gov.
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.
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 discovery
through Phase 3 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).
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 for the treatment
of ulcerative colitis and other inflammatory diseases and the
possibility that the parties may be unable to complete such trials
in the currently anticipated timelines or at all. Further, the
regulatory submissions of filgotinib for the treatment of
rheumatoid arthritis that are currently under review by the FDA,
European Medicines Agency and Japan’s Ministry of Health, Labour
and Welfare may not be approved in the currently anticipated
timelines or at all, and any marketing approvals, if granted, may
have significant limitations on its use. It is also 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 Form 10-Q for
the quarter ended March 31, 2020, 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.
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 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.
i McMullan, C. et al. BMJ Open 2017: Adapting to ulcerative
colitis to try to live a ‘normal’ life. Available at:
https://bmjopen.bmj.com/content/bmjopen/7/8/e017544.full.pdf.
Accessed May 2020. ii Gilead & Galapagos Filgotinib Clinical
Program Trial Details: FINCH 1 (NCT02889796); FINCH 2
(NCT02873936); FINCH 3 (NCT02886728); SELECTION (NCT02914522);
DIVERSITY (NCT02914561); PENGUIN 1 (NCT04115748); PENGUIN 2
(NCT04115839)
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Gilead Douglas Maffei, PhD, Investors +1 (650) 522-2739
Arran Attridge, Media +1 (650) 425-8975
Galapagos Elizabeth Goodwin, Investors +1 (781) 460-1784
Carmen Vroonen, Media +32 473 824 874
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