-- 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 --
Foster City, Calif., and Mechelen,
Belgium, May 20, 2020, 22.01 CET; regulated information –
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.
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
CollaborationiiGilead and Galapagos 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 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 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
StatementThis 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.
# # #
Galapagos
contactsInvestors:
Media:Elizabeth
Goodwin
Carmen Vroonen VP
IR
Senior Director
Communications+1-781-460-1784
+32 473 824
874
Sofie Van Gijsel
Evelyn FoxDirector IR
Director Communications+32 485 19 14
15
+31 6 53 591
999ir@glpg.com
communications@glpg.com
Gilead
contactsInvestors:
Media:Douglas Maffei,
PhD
Arran Attridge+1 (650)
522-2739
+1 (650) 425-8975
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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