- Analyst call will be held to discuss data
today at 4:00 PM Eastern Time
Pfizer Inc. (NYSE: PFE) today announced detailed results from
two pivotal studies that make up the ELEVATE UC Phase 3
registrational program evaluating etrasimod, a once-daily, oral,
selective sphingosine 1-phosphate (S1P) receptor modulator for the
treatment of moderately-to-severely active ulcerative colitis (UC).
These data were presented as a late-breaker presentation (abstract
number 968a) at Digestive Disease Week (DDW) 2022.
Both Phase 3, multi-center, randomized, placebo-controlled
trials achieved all primary and key secondary endpoints, with
etrasimod demonstrating a safety profile consistent with previous
studies. In the 52-week ELEVATE UC 52 study, clinical remission was
27.0% for patients receiving etrasimod compared to 7.4% for
patients receiving placebo at week 12 (19.8% differential, P=˂.001)
and was 32.1% compared to 6.7% at week 52 (25.4% differential,
P=˂.001). In the 12-week ELEVATE UC 12 study, clinical remission
was achieved among 24.8% of patients receiving etrasimod compared
to 15.2% of patients receiving placebo (9.7% differential,
P=.0264).
UC is a chronic and often debilitating inflammatory bowel
disease1 that affects an estimated 3.8 million people in North
America and Europe.2 Symptoms of UC can include chronic diarrhea
with blood and mucus, abdominal pain and urgency.3,4 UC can have a
significant effect on work, family and social activities.4
“Etrasimod could offer a differentiated clinical profile for
people living with moderately-to-severely active ulcerative colitis
considering the clear benefit it has shown over 52 weeks in a
treat-through trial design, its mechanism of action, and its unique
pharmacologic properties,” said Michael Corbo, Chief Development
Officer, Inflammation & Immunology, Pfizer Global Product
Development. “Patients often need multiple options to help manage
their disease and there is a significant need for new therapies. In
the ELEVATE clinical program, etrasimod has shown an encouraging
balance of efficacy and safety that we believe could have a
meaningful impact for patients and physicians, if approved.”
The 52-week ELEVATE UC 52 trial utilized a treat-through design
which closely mimics real-world clinical practice. Statistically
significant improvements were attained in all key secondary
endpoints in ELEVATE UC 52. These included endoscopic improvement,
symptomatic remission, and mucosal healing at weeks 12 and 52, and
corticosteroid-free remission and sustained clinical remission at
week 52. All key secondary endpoints were also met at week 12 in
ELEVATE UC 12. These included endoscopic improvement, symptomatic
remission, and mucosal healing.
Treatment-emergent adverse events (AEs), including serious AEs,
were similar between treatment groups in both trials. The most
common treatment-emergent AEs in 3% or more of etrasimod-treated
patients and greater than placebo up to week 52 in either trial
were headache, worsening of UC, COVID-19 infection, dizziness,
pyrexia, arthralgia, abdominal pain and nausea. There were no
reports of bradycardia or atrioventricular block as serious
AEs.
The data from ELEVATE UC 52 & UC 12 are expected to form the
basis for planned future regulatory filings, which will be
initiated later this year. Additional information about the studies
can be found at www.clinicaltrials.gov under the identifiers
NCT03945188, NCT03996369, and NCT03950232.
Etrasimod was developed by Arena Pharmaceuticals, which was
recently acquired by Pfizer.
Pfizer Conference Call
Pfizer Inc. invites Pfizer investors and the general public to
view and listen to a webcast of a live conference call with
investment analysts at 4 p.m. ET on May 24.
To view and listen to the webcast visit Pfizer’s website at
www.pfizer.com/investors or directly at
https://pfizer.rev.vbrick.com/#/events/333186b6-252b-4c60-be45-947638abd93f.
Information on accessing and pre-registering for the webcast will
be available at www.pfizer.com/investors beginning today.
Participants are advised to pre-register in advance of the
conference call.
You can listen to the conference call by dialing either (833)
708-1779 in the United States or Canada or (602) 585-9859 outside
of the United States and Canada. The password is “9991403.” Please
join the call five minutes prior to the start time to avoid
operator hold times.
The transcript and webcast replay of the call will be made
available on Pfizer’s website at www.pfizer.com/investors within 24
hours after the end of the live conference call and will be
accessible for at least 90 days.
About Etrasimod
Etrasimod is an oral, once-a-day, selective sphingosine
1-phosphate (S1P) receptor modulator designed for optimized
pharmacology and engagement of S1P receptors 1, 4, and 5. It is
being investigated for a range of immuno-inflammatory diseases,
including ulcerative colitis, Crohn’s disease, atopic dermatitis,
eosinophilic esophagitis, and alopecia areata.
About ELEVATE UC 52 and ELEVATE UC 12
ELEVATE UC 52 and ELEVATE UC 12 are pivotal trials that are part
of the ELEVATE UC Phase 3 registrational program.
ELEVATE UC 52 is a randomized, double-blind, placebo-controlled
trial that utilized a treat-through design. The primary objective
of this trial was to assess the safety and efficacy of etrasimod 2
mg once-daily on clinical remission after both 12 and 52 weeks. All
patients that dropped out of the study across either treatment arm
over the 52-week study was counted as a non-responder. The primary
endpoint is based on the 3-domain, modified Mayo score (MMS). Key
secondary measures included endoscopic improvement, symptomatic
remission, and mucosal healing at weeks 12 and 52, and
corticosteroid free remission and sustained clinical remission at
week 52.
ELEVATE UC 12 is a randomized, double-blind, placebo-controlled
trial to assess the efficacy and safety of etrasimod 2 mg
once-daily in subjects with moderately-to-severely active UC. The
primary objective of this trial was to assess the safety and
efficacy of etrasimod on clinical remission at 12 weeks assessed by
the FDA-required, 3-domain, modified Mayo score. Key secondary
measures included endoscopic improvement, symptomatic remission,
and mucosal healing.
62.6% of etrasimod-treated patients in both trials and 61.8% and
62.9% of placebo-treated patients in ELEVATE UC 52 and ELEVATE UC
12, respectively, were naïve to biologic or JAK inhibitor
therapy.
About Digestive Disease Week
Digestive Disease Week® (DDW) is the largest international
gathering of physicians, researchers and academics in the fields of
gastroenterology, hepatology, endoscopy and gastrointestinal
surgery. Jointly sponsored by the American Association for the
Study of Liver Diseases (AASLD), the American Gastroenterological
Association (AGA) Institute, the American Society for
Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of
the Alimentary Tract (SSAT), DDW is an in-person and virtual
meeting from May 21-24, 2022. The meeting showcases more than 3,100
abstracts and hundreds of lectures on the latest advances in GI
research, medicine and technology. More information can be found at
www.ddw.org.
About Pfizer Inflammation & Immunology
At Pfizer Inflammation & Immunology, we strive to deliver
breakthroughs that enable freedom from day-to-day suffering for
people living with autoimmune and chronic inflammatory diseases,
which can be debilitating, disfiguring and distressing,
dramatically affecting what they can do. With a focus on
immuno-inflammatory conditions in Rheumatology, Gastroenterology
and Medical Dermatology, our current portfolio of approved
medicines and investigational molecules spans multiple action and
delivery mechanisms, from topicals to small molecules, biologics
and biosimilars. The root cause of many immunological diseases is
immuno-inflammation, which requires specifically designed agents.
Our differentiated R&D approach resulted in one of the broadest
pipelines in the industry, where we purposefully match molecules to
diseases where we believe they can make the biggest difference.
Building on our decades-long commitment and pioneering science, we
continue to advance the standard of care for patients living with
immuno-inflammatory diseases and are working hand-in-hand with
patients, caregivers and the broader healthcare community on
healthcare solutions for the many challenges of managing chronic
inflammatory diseases, allowing patients to live their best
lives.
Pfizer Inc.: Breakthroughs that Change Patients’
Lives
At Pfizer, we apply science and our global resources to bring
therapies to people that extend and significantly improve their
lives. We strive to set the standard for quality, safety, and value
in the discovery, development, and manufacture of health care
products, including innovative medicines and vaccines. Every day,
Pfizer colleagues work across developed and emerging markets to
advance wellness, prevention, treatments, and cures that challenge
the most feared diseases of our time. Consistent with our
responsibility as one of the world's premier innovative
biopharmaceutical companies, we collaborate with health care
providers, governments, and local communities to support and expand
access to reliable, affordable health care around the world. For
more than 170 years, we have worked to make a difference for all
who rely on us. We routinely post information that may be important
to investors on our website at www.pfizer.com. In addition, to
learn more, please visit us on www.pfizer.com and follow us on
Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube and like us
on Facebook at Facebook.com/Pfizer.
Disclosure Notice
The information contained in this release is as of May 24, 2022.
Pfizer assumes no obligation to update forward-looking statements
contained in this release as the result of new information or
future events or developments.
This release contains forward-looking information about
etrasimod, including its potential benefits and planned regulatory
filings, that involves substantial risks and uncertainties that
could cause actual results to differ materially from those
expressed or implied by such statements. Risks and uncertainties
include, among other things, the uncertainties inherent in research
and development, including the ability to meet anticipated clinical
endpoints, commencement and/or completion dates for our clinical
trials, regulatory submission dates, regulatory approval dates
and/or launch dates, as well as the possibility of unfavorable new
clinical data and further analyses of existing clinical data; the
risk that clinical trial data are subject to differing
interpretations and assessments by regulatory authorities; whether
regulatory authorities will be satisfied with the design of and
results from our clinical studies; whether and when drug
applications may be filed in any jurisdictions for etrasimod;
whether and when any such applications may be approved by
regulatory authorities, which will depend on myriad factors,
including making a determination as to whether the product's
benefits outweigh its known risks and determination of the
product's efficacy and, if approved, whether etrasimod will be
commercially successful; decisions by regulatory authorities
impacting labeling, manufacturing processes, safety and/or other
matters that could affect the availability or commercial potential
of etrasimod; the impact of COVID-19 on Pfizer’s business,
operations and financial results; and competitive developments.
A further description of risks and uncertainties can be found in
Pfizer’s Annual Report on Form 10-K for the fiscal year ended
December 31, 2021 and in its subsequent reports on Form 10-Q,
including in the sections thereof captioned “Risk Factors” and
“Forward-Looking Information and Factors That May Affect Future
Results”, as well as in its subsequent reports on Form 8-K, all of
which are filed with the U.S. Securities and Exchange Commission
and available at www.sec.gov and www.pfizer.com.
__________________________________ 1 Crohn’s and Colitis
Foundation. What is Ulcerative Colitis. Available at: What is
Ulcerative Colitis? | Crohn's & Colitis Foundation
(crohnscolitisfoundation.org). Accessed April 26, 2022. 2 Seyedian,
SS. A review of the diagnosis, prevention, and treatment methods of
inflammatory bowel disease. J Med Life. 2019;12(2):113-122.
Available at: A review of the diagnosis, prevention, and treatment
methods of inflammatory bowel disease - PMC (nih.gov). Accessed
April 26, 2022. 3 Hanauer SB. Inflammatory bowel disease. N Engl J
Med. 1996;334(13):841-8. Available at: Inflammatory Bowel Disease |
NEJM. Accessed April 26, 2022. 4 Irvine EJ. Quality of Life of
Patients with Ulcerative Colitis: Past, Present, and Future.
Inflammatory Bowel Diseases. 2008;14(4):554-563. Available at:
Quality of life of patients with ulcerative colitis: Past, present,
and future | Inflammatory Bowel Diseases | Oxford Academic
(openathens.net). Accessed April 26, 2022.
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