–Study achieves all co-primary and key
secondary endpoints–
–Safety results show both doses of
abrocitinib consistent with prior clinical trial
experiences–
Pfizer Inc. (NYSE: PFE) announced today positive top-line
results from a second Phase 3 pivotal study evaluating the efficacy
and safety of its investigational oral Janus kinase 1 (JAK1)
inhibitor, abrocitinib, in patients aged 12 and older with moderate
to severe atopic dermatitis (AD). This is the second monotherapy
trial in the JAK1 Atopic Dermatitis Efficacy and Safety (JADE)
global development program (B7451013, or JADE MONO-2). Pfizer
announced positive top-line results from the first trial in the
JADE program (B7451012, or JADE MONO-1) on May 15, 2019. Complete
results from JADE MONO-1 will be presented as a late-breaking
abstract at a major upcoming European scientific meeting in Madrid
in October 2019.
JADE MONO-2 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.
Consistent with JADE MONO-1, 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, a
statistically significant number of patients achieved a reduction
in pruritus by week two, as measured by a four-point or larger
reduction in itch severity measured with the pruritus numerical
rating scale (NRS).
“These findings add to a growing body of evidence supporting the
potential of abrocitinib to improve the lives of people living with
moderate to severe atopic dermatitis,” said Michael Corbo, PhD,
Chief Development Officer, Inflammation & Immunology, Pfizer
Global Product Development. “We look forward to continued findings
from the JADE program, with results from the next abrocitinib
efficacy study, using an active control, becoming available in
spring 2020. This will further our understanding of abrocitinib as
a potential medicine for patients who suffer from this chronic
condition.”
The co-primary study endpoints in JADE MONO-2 were the
proportion of patients who achieved an Investigator Global
Assessment (IGA) score of clear (0) or almost clear (1) skin and
two-point or greater 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
four-point or larger reduction in itch severity measured with the
pruritus NRS and the magnitude of decrease in the Pruritus and
Symptoms Assessment for Atopic Dermatitis (PSAAD).
Safety results showed that both doses of abrocitinib were
well-tolerated and were broadly consistent with JADE MONO-1. The
frequency of treatment-emergent adverse events were 54%, 63%, and
66% for placebo, 100mg, and 200mg, respectively. The frequency of
Serious Adverse Events were 1.3%, 3.2%, and 1.3% for placebo,
100mg, and 200mg, respectively. One patient with co-existing
cardiovascular risk factors died from unknown etiology three weeks
after completing treatment with abrocitinib 100mg once daily, which
was deemed unrelated to the study drug by the investigator. The
discontinuation rates due to an adverse event were low in each
treatment arm (3.8% and 3.2% in 100mg and 200mg, respectively)
compared to placebo (12.8%).
Full results from JADE MONO-2 will be submitted for presentation
at a future scientific meeting and publication in a medical
journal.
Additional Details About the Study
A total of 391 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.
JADE MONO-2 is the second trial in the JAK1 Atopic Dermatitis
Efficacy and Safety (JADE) global development program. Additional
data from other studies in the JADE program will be available later
this year and early next.
For additional information about JADE MONO-2, please visit
https://www.clinicaltrials.gov.
About Abrocitinib
Abrocitinib 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 up to 10% of adults and up to 20% of children
worldwide.4,5
About Pfizer’s Immunokinase 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.6 JAK inhibition may offer patients with
these conditions a potential new advanced treatment option.7
Pfizer’s leading JAK biology and chemistry expertise from years
of JAK research experience, has enabled the company to take a
different R&D approach, resulting in the broadest immunokinase
inhibitor pipeline. Instead of studying a single molecule for all
its potential uses, where it may not be optimal for some, Pfizer’s
candidates are purposefully matched to the conditions where we
believe they have the greatest potential to, if approved, address
unmet need. Pfizer has five unique immunokinase inhibitors in
late-stage clinical trials for the potential treatment of nine
immune-mediated diseases:
- Abrocitinib: A JAK inhibitor in Phase 3 clinical trials for the
treatment of moderate-to-severe AD among adolescents and
adults
- PF-06651600: An oral, JAK3/TEC family kinase inhibitor in Phase
3 clinical trial for the treatment of alopecia areata (AA) and in
Phase 2 for vitiligo, Crohn’s disease (CD), and ulcerative colitis
(UC)
- PF-06700841: A tyrosine kinase 2(TYK2)/JAK1 inhibitor in Phase
2 clinical trials for the treatment of psoriasis and AD in topical
formulation, and, in oral formulation for psoriatic arthritis, CD,
UC, vitiligo, systemic lupus erythematosus (SLE), and AA
- PF-06826647: A TYK2 inhibitor under investigation in Phase 2
clinical trials for the treatment of psoriasis
- PF-06650833: An IL-1 receptor associated kinase 4 (IRAK4)
inhibitor under investigation for the treatment of rheumatoid
arthritis in Phase 2 clinical trial
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 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 September 27, 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, 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 August 16, 2019. 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 Oszukowska M, Michalak I, Gutfreund K, et al.
Role of primary and secondary prevention in atopic dermatitis.
Postep Derm Alergol. 2015:32(6):409-420. 5 Nutten S. Atopic
dermatitis: global epidemiology and risk factors. Ann Nutr Metab.
2015;66(suppl 1):8-16. 6 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. 7 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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Media: Steve Danehy 212-733-1538 Steven.Danehy@pfizer.com
Investors: Bryan Dunn 212-733-8917 Bryan.Dunn@pfizer.com
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