Study achieves all co-primary and secondary
endpoints
Pfizer Inc. (NYSE: PFE) announced today positive top-line
results from a Phase 3 pivotal study (B7451012) evaluating the
efficacy and safety of its investigational oral Janus kinase 1
(JAK1) inhibitor, abrocitinib (PF-04965842), in patients aged 12
and older with moderate to severe atopic dermatitis (AD).
B7451012 was a randomized, double-blind, placebo-controlled,
parallel-group study designed to evaluate the efficacy and safety
of two doses (100mg and 200mg once daily) of abrocitinib
monotherapy over 12 weeks. Top-line results showed that by week 12
the percentage of patients achieving each co-primary efficacy
endpoint and each key secondary endpoint with either dose of
abrocitinib was statistically significantly higher than placebo. In
addition, the results demonstrate response to treatment for a
statistically significant number of patients during the first two
to four weeks following first dose.
“Moderate to severe atopic dermatitis is a chronic, inflammatory
skin disease that can take both a physical and emotional toll on
the millions of patients living with the condition worldwide,” said
Michael Corbo, PhD, Chief Development Officer, Inflammation &
Immunology, Pfizer Global Product Development. “These top-line
findings are encouraging and provide evidence that abrocitinib, if
approved, could be an effective new oral once-daily treatment
option for patients.”
The co-primary study endpoints were the proportion of patients
who achieved an Investigator Global Assessment (IGA) score of clear
(0) or almost clear (1) skin and ≥2 point improvement; and the
proportion of patients who achieved at least a 75% or greater
change from baseline in their Eczema Area and Severity Index (EASI)
score. The key secondary endpoints were the proportion of patients
achieving a 4 point or larger reduction in itch severity measured
with the pruritus numerical rating scale (NRS) and the magnitude of
decrease in the Pruritus and Symptoms Assessment for Atopic
Dermatitis (PSAAD).
Safety results show that both doses of abrocitinib were
well-tolerated, and there were no unexpected safety events. The
discontinuation rates due to an adverse event were low in each
treatment arm (5.8% and 5.8% in 100mg and 200mg) compared to
placebo (9.1%).
Additional Details About the Study
A total of 387 subjects were randomized to abrocitinib 200mg,
abrocitinib 100mg, and placebo in the trial. Randomization was
stratified by baseline disease severity (moderate [IGA=3] and
severe [IGA=4] AD) and age (age <18 and ≥18 years).
Eligible subjects completing the 12-week treatment period of the
study had the option to enter a long-term extension (LTE), study
B7451015. Subjects discontinuing early from treatment, or who were
otherwise ineligible for the LTE study, entered a 4-week follow up
period in this study.
Detailed analyses of B7451012, including additional efficacy and
safety data, will be submitted for presentation at a future
scientific meeting and published in a prominent medical journal.
B7451012 is the first trial in the JAK1 Atopic Dermatitis Efficacy
and Safety (JADE) global development program. Additional data from
another study in the JADE program will be available later this
year.
For additional information about B7451012, please visit
https://www.clinicaltrials.gov.
About Abrocitinib (PF-04965842)
Abrocitinib (PF-04965842) is an oral small molecule that
selectively inhibits Janus kinase (JAK) 1. Inhibition of JAK1 is
thought to modulate multiple cytokines involved in pathophysiology
of AD including interleukin (IL)-4, IL-13, IL-31, and interferon
gamma.
Abrocitinib received Breakthrough Therapy designation from the
U.S. Food and Drug Administration (FDA) for the treatment of
patients with moderate to severe AD in February 2018. Breakthrough
Therapy designation was initiated as part of the Food and Drug
Administration Safety and Innovation Act (FDASIA) signed in 2012.
As defined by the FDA, a breakthrough therapy is a drug intended to
be used alone or in combination with one or more other drugs to
treat a serious or life-threatening disease or condition, and
preliminary clinical evidence indicates that the drug may
demonstrate substantial improvement over existing therapies on one
or more clinically significant endpoints, such as substantial
treatment effects observed early in clinical development. If a drug
is designated as a Breakthrough Therapy, the FDA will expedite the
development and review of such drug.1
About Atopic Dermatitis
AD is a chronic skin disease characterized by inflammation of
the skin and skin barrier defects.2,3 Lesions of AD are
characterized by erythema (redness), itching, induration
(hardening)/papulation (formulation of papules), and
oozing/crusting.2,3
AD is one of the most common, chronic, relapsing childhood
dermatoses, affecting 1% to 3% of adults and 15% to 20% of children
worldwide.4 Approximately 50% of pediatric AD patients globally
have recurrent symptoms into adolescence and adulthood.5,6
About Pfizer’s Kinase Inhibitor Leadership
The JAK pathways are believed to play an important role in
inflammatory processes as they are involved in signaling for over
50 cytokines and growth factors, many of which drive
immune-mediated conditions.7 JAK inhibition may offer patients with
these conditions a potential new advanced treatment option.8
Pfizer has established a leading kinase research capability with
multiple unique kinase inhibitor therapies in development. As a
pioneer in JAK science, the company is continuing to advance
several investigational programs for molecules with novel
selectivity profiles, which, if approved, could potentially deliver
transformative therapies for patients. In addition to abrocitinib,
Pfizer has several kinase inhibitors in clinical trials across
multiple indications, including:
- PF-06700841: A tyrosine kinase
2(TYK2)/JAK1 inhibitor under investigation for the treatment of
psoriasis, Crohn’s disease, ulcerative colitis, vitiligo, and
alopecia areata
- PF-06650833: An IL-1 receptor
associated kinase 4 (IRAK4) inhibitor under investigation for the
treatment of rheumatoid arthritis
- PF-06826647: A TYK2 inhibitor under
investigation for the treatment of inflammatory bowel disease
(IBD)
- PF-06651600: An oral, JAK3 inhibitor
under investigation for the treatment of alopecia areata, vitiligo,
rheumatoid arthritis, Crohn’s disease, and ulcerative colitis
Working Together For a Healthier World®
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. Our global portfolio includes medicines and vaccines as
well as many of the world's best-known consumer health care
products. 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 150 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 15, 2019. 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 a
product candidate, abrocitinib (PF-04965842), and Pfizer’s ongoing
investigational programs in kinase inhibitor therapies, including
their potential benefits, 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 any
potential indication for abrocitinib or any other investigational
kinase inhibitor therapies; 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 abrocitinib or
any such other investigational kinase inhibitor therapies 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 abrocitinib or any other investigational kinase inhibitor
therapies; 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, 2018 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 U.S. Food and Drug Administration. Fact Sheet: Breakthrough
Therapies at
https://www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/SignificantA...
accessed on January 25, 2018.
2 Hanifin JM, Reed ML. A population-based survey of eczema in
the United States. Dermatitis. 2007;18(2):82-91.
3 Bieber T. Atopic dermatitis. Dermatology.
2012;1(3):203-217.
4 Nutten S. Atopic dermatitis: global epidemiology and risk
factors. Ann Nutr Metab. 2015;66(suppl 1):8-16.
5 Williams HC Atopic Dermatitis 2005 N Eng J med 2005;
352:2314-2324 (v1.0).
6 Leung_2013 (v1.0).
7 Banerjee, S., Biehl, A., Gadina, M. et al. JAK–STAT Signaling
as a Target for Inflammatory and Autoimmune Diseases: Current and
Future Prospects. Drugs. 2017;77: 521.
https://doi.org/10.1007/s40265-017-0701-9.
8 Telliez JB, Dowty ME, Wang L, Jussif J, Lin T, Li L, et al.
Discovery of a JAK3-selective inhibitor: functional differentiation
of JAK3-selective inhibition over pan-JAK or JAK1-selective
inhibition. ACS Chem Biol. 2016;11(12):3442–51.
doi:10.1021/acschembio.6b00677.
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version on businesswire.com: https://www.businesswire.com/news/home/20190515005265/en/
Media:Steve Danehy, 212-733-1538Steven.Danehy@pfizer.com
Investors:Bryan Dunn, 212-733-8917Bryan.Dunn@pfizer.com
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