-- Filgotinib 200mg Achieved Endoscopic,
Histologic and Six-Month Corticosteroid-Free Remission at Week 58
with a Consistent Safety Profile --
-- Study Enrolled Biologic-Naïve and
Biologic-Experienced Patients, a High Proportion of Whom Were
Highly Refractory --
Gilead Sciences, Inc. (Nasdaq: GILD) and Galapagos NV (Euronext
& Nasdaq: GLPG) today presented late-breaking data
demonstrating sustained efficacy and safety with filgotinib, an
investigational, oral, once-daily, JAK1 preferential inhibitor, for
the treatment of moderately to severely active ulcerative colitis
(UC). The data from the randomized, double-blind,
placebo-controlled, Phase 2b/3 SELECTION trial showed that a
significantly higher proportion of patients treated with filgotinib
200 mg, versus placebo, achieved clinical remission at Week 10 and
maintained remission through Week 58. In addition, significantly
more patients achieved six-month corticosteroid-free remission. The
full results were presented today at the 2020 United European
Gastroenterology Week (UEGW) Virtual Meeting (Abstracts #LB19 and
#LB20).
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UC is a longer-term condition characterized by inflammation of
the mucosal lining of the colon and rectum. An increasingly
prevalent disease, UC has a significant impact on the quality of
life of more than 2 million people around the world. Despite
current treatments, many patients experience fecal urgency,
incontinence, recurring bloody diarrhea and the need to empty their
bowels frequently, often accompanied by abdominal pain, poor sleep
and fatigue.
“There remains a tremendous need for treatments that can achieve
meaningful and sustained clinical outcomes in ulcerative colitis,”
said Laurent Peyrin-Biroulet, MD, PhD, Gastroenterology Department
at Lorraine University in France, and presenting investigator of
the SELECTION maintenance study. “These study results showed that
filgotinib reduced bleeding and stool frequency while also
achieving remission across a range of measures, including endoscopy
and histology, in an oral formulation.”
The SELECTION study included biologic-naïve patients, for whom
prior conventional therapy had failed, as well as
biologic-experienced patients – a high proportion of whom had been
non-responders to at least two different lines of prior biologics.
In total, 43 percent of patients in the biologic-experienced cohort
had failed treatment with both a TNF inhibitor and vedolizumab. The
study allowed the enrollment of patients who were taking steroids,
and/or immunomodulators, including methotrexate, mercaptopurine
(6-MP) or azathioprine, as they would in real-world clinical
practice.
Efficacy Data of Filgotinib in Induction
and Maintenance
Overall, 1,348 biologic-naïve or biologic-experienced adult
patients with moderately to severely active UC were randomized and
treated in the SELECTION study. Among biologic-naïve patients
treated with filgotinib 200 mg, a significantly higher proportion
of patients achieved clinical remission at Week 10 compared with
placebo (26.1% vs. 15.3%, p=0.0157). Additionally, a significantly
higher proportion of biologic-naïve patients treated with
filgotinib 200 mg versus placebo achieved Mayo Clinic Score (MCS)
remission (24.5% vs. 12.4%, p=0.0053), endoscopic remission (12.2%
vs. 3.6%, p=0.0047) and histologic remission (35.1% vs. 16.1%,
p<0.0001). A significantly higher proportion of
biologic-experienced patients treated with filgotinib 200mg
achieved clinical remission at Week 10 compared with placebo (11.5%
vs. 4.2%, p=0.0103).
Patients treated with filgotinib who achieved clinical response
or remission at Week 10 were re-randomized to their induction dose
of filgotinib or placebo in a 2:1 ratio and treated through Week 58
(Maintenance Trial, n=558). At Week 58, 37.2 percent of patients
receiving filgotinib 200 mg achieved clinical remission, compared
with 11.2 percent of patients treated with placebo (p˂0.0001). A
significantly higher proportion of those treated with filgotinib
200 mg versus placebo achieved sustained clinical remission (18.1%
vs. 5.1%, p=0.0024), MCS remission (34.7% vs. 9.2%, p<0.0001),
endoscopic remission (15.6% vs. 6.1%, p=0.0157) and histologic
remission (38.2% vs. 13.3%, p<0.0001). Additionally, a
significantly higher proportion of patients treated with filgotinib
200 mg achieved six-month corticosteroid-free clinical remission at
Week 58 compared with placebo (27.2% vs. 6.4%, p=0.0055).
Safety Outcomes with Filgotinib in
Ulcerative Colitis
Overall, the incidence of adverse events (AEs), serious AEs and
discontinuations due to AEs were similar in the filgotinib and
placebo groups in both the induction and maintenance periods of the
study. Serious infections, herpes zoster, venous thrombosis,
pulmonary embolism and gastrointestinal perforation were infrequent
and comparable across treatment groups. The most common adverse
events of interest in the induction trials were serious infections
(1.1% filgotinib 100 mg, 0.6% filgotinib 200 mg, 1.1% placebo),
herpes zoster (0.2% filgotinib 100 mg, 0.6% filgotinib 200 mg, 0.0%
placebo), opportunistic infections (0.0% filgotinib 100 mg, 0.2%
filgotinib 200 mg, 0.0% placebo) and pulmonary embolism (0.0%
filgotinib 100 mg, 0.2% filgotinib 200 mg, 0.0% placebo). In the
maintenance trial, the most common adverse events of interest were
serious infections (1.7% filgotinib 100 mg, 1.0% filgotinib 200 mg,
1.1% placebo), herpes zoster (0.0% filgotinib 100 mg, 0.5%
filgotinib 200 mg, 0.0% placebo) and venous thrombosis (0.0%
filgotinib 100 mg, 0.0% filgotinib 200 mg, 2.2% placebo). Two
deaths were observed in the filgotinib 200 mg treatment group in
the maintenance trial; both adverse events leading to deaths were
considered by the study investigators to be unrelated to study
drug.
“Ulcerative colitis is a complex and unpredictable condition
that can impact people in the prime of their lives. Despite
treatment, people with UC can experience symptoms that have a
significant impact on their quality of life,” said Mark Genovese,
MD, Senior Vice President, Inflammation, Gilead Sciences. “We are
pleased to share these data on the use of filgotinib in UC as we
work to identify new treatment options to address unmet needs
across a range of inflammatory diseases.”
“The SELECTION study assessed the efficacy and safety of
filgotinib in some of the most difficult-to-treat patients with
ulcerative colitis, including a high proportion of patients who
were refractory to biologic treatment and in need of new treatment
options,” said Dr. Walid Abi-Saab, Chief Medical Officer,
Galapagos. “The efficacy and safety data seen with filgotinib in
this patient population add to the growing body of evidence
demonstrating the potential this once-daily treatment may offer
patients living with this debilitating condition.”
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 JAK1 preferential inhibitor, filgotinib in adult
patients with moderately to severely active UC. The SELECTION trial
comprises two induction trials and a maintenance trial. The
Induction Study A enrolled biologic-naïve patients, and the
Induction Study B 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 were to evaluate the
efficacy of filgotinib compared with placebo in establishing
clinical remission as determined by the Mayo 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 in the induction studies and Week 58 in the maintenance
study. Eligible patients who were enrolled in the SELECTION trial
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 Filgotinib
Filgotinib (200 mg and 100 mg tablets) is approved in Europe and
Japan for the treatment of adults with moderately to severely
active rheumatoid arthritis (RA) who have responded inadequately or
are intolerant to one or more disease modifying anti-rheumatic
drugs (DMARDs). Full European Summary of Product Characteristics
for filgotinib are available from the European Medicines Agency
(EMA) website at www.ema.europa.eu and the interview form from the
Japanese Ministry of Health, Labour and Welfare (MHLW) is available
at www.info.pmda.go.jp. Filgotinib is not approved anywhere for the
treatment of ulcerative colitis.
About the Filgotinib
Collaboration
Gilead and Galapagos NV are collaborative partners in the global
development of filgotinib in rheumatoid arthritis, inflammatory
bowel disease and other inflammatory indications. The companies are
conducting global studies investigating the potential role of
filgotinib in a variety of diseases, including the Phase 3
SELECTION trial in UC and an actively enrolling Phase 3 trial in
Crohn’s Disease (DIVERSITY).
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 NV 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.
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. There
is also the possibility of unfavorable results from ongoing and
additional clinical trials involving filgotinib, including the
SELECTION long-term extension trial and the DIVERSITY trial.
Further, it is possible that the parties may make a strategic
decision to discontinue development of filgotinib for the treatment
of ulcerative colitis or other indications, and as a result,
filgotinib may never be successfully commercialized for the
treatment of ulcerative colitis or other indications. 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 June 30, 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 press release includes forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, as amended, that are subject to risks, uncertainties and
other factors that could cause actual results to differ materially
from those referred to in the forward-looking statements and,
therefore, the reader should not place undue reliance on them.
These risks, uncertainties and other factors include, without
limitation, the risk that ongoing and future clinical studies with
filgotinib may not be completed in the currently envisaged
timelines or at all, 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 for
ulcerative colitis or other indications due to safety, efficacy or
other reasons), Galapagos' reliance on collaborations with third
parties (including our collaboration partner for filgotinib,
Gilead) and that Galapagos’ estimations regarding its filgotinib
development program and regarding the commercial potential of
filgotinib, may be incorrect, as well as those risks and
uncertainties identified in our Annual Report on Form 20-F for the
year ended 31 December 2019 and our subsequent filings with the
SEC. All statements other than statements of historical fact are
statements that could be deemed forward-looking statements. The
forward-looking statements contained herein are based on
management’s current expectations and beliefs and speak only as of
the date hereof, and Galapagos makes no commitment to update or
publicly release any revisions to forward-looking statements in
order to reflect new information or subsequent events,
circumstances or changes in expectations.
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Gilead Douglas Maffei, PhD, Investors +1 (650) 522-2739
Marian Cutler, Media +1 (973) 517-0519 Galapagos Elizabeth
Goodwin, Investors +1 (781) 460-1784 Carmen Vroonen, Media +32 473
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