–Abrocitinib met all co-primary and
secondary endpoints in JADE MONO-1 study–
–Findings follow recent positive top-line
results for second abrocitinib Phase 3 pivotal study, JADE
MONO-2–
Pfizer Inc. (NYSE: PFE) announced today complete results from a
Phase 3, 12-week, pivotal study (JADE MONO-1) in patients aged 12
and older with moderate to severe atopic dermatitis (AD).
Abrocitinib, an investigational oral Janus kinase 1 (JAK1)
inhibitor, met all the co-primary and key secondary endpoints,
which were related to skin clearance and itch relief compared to
placebo. Safety data showed that both evaluated doses of
abrocitinib (200mg and 100mg) were well tolerated and were
consistent with a companion study (JADE MONO-2) from the JAK1
Atopic Dermatitis Efficacy and Safety (JADE) global development
program. The results were shared as a Late-Breaking presentation at
the 28th Congress of the European Academy of Dermatology and
Venereology (EADV) taking place October 9-13, 2019 in Madrid,
Spain.
The co-primary study endpoints in JADE MONO-1 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 relative to baseline; 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 numerical rating scale (NRS), and the
magnitude of decrease in the Pruritus and Symptoms Assessment for
Atopic Dermatitis (PSAAD), a patient-reported measurement scale
developed by Pfizer. Other secondary endpoints included the
proportion of patients who achieved a 90% or greater change in EASI
score, and the percentage change from baseline in their SCORing
Atopic Dermatitis (SCORAD) response at all scheduled time
points.
“There is a critical need for additional treatment options for
patients living with moderate to severe atopic dermatitis,” said
Michael Corbo, PhD, Chief Development Officer, Inflammation &
Immunology, Pfizer Global Product Development. “We are pleased by
these findings, which together with the recently reported positive
top-line results from our second Phase 3 trial, encourage us that,
if approved, abrocitinib may provide the first oral, once-daily
treatment option for these patients.”
JADE MONO-1 Study Efficacy Results1
Both doses of abrocitinib significantly improved the IGA and
EASI-75 dose response outcomes compared to placebo. By week 12, the
following co-primary efficacy and secondary endpoint results were
seen:
Abrocitinib 200mg (N=154)
Abrocitinib 100mg (N=156)
Placebo (N=77)
IGA Response Rate
43.8%
23.7%
7.9%
EASI-75 Response Rate
62.7%
39.7%
11.8%
NRS ≥4-Point Improvement Response Rate
57.2%
37.7%
15.3%
EASI-90 Response Rate
38.6%
18.6%
5.3%
The percentage changes in SCORAD were significantly greater at
all time points in the 200mg and 100mg treatment arms compared to
placebo.
JADE MONO-1 Safety Results1
The most frequently reported treatment-emergent adverse events
in abrocitinib-treated patients (200mg, 100mg) were short-lasting
nausea (20.1%, 9.0%), headache (9.7%, 7.7%), and nasopharyngitis
(11.7%, 14.7%), while for placebo, it was dermatitis (16.9%).
Observed serious adverse events (SAEs) for abrocitinib 200mg were
inflammatory bowel disease, peritonsillitis, dehydration, and
asthma (2 cases). SAEs seen for the 100mg dose included retinal
detachment, acute pancreatitis, appendicitis, dizziness, and
seizures. In the placebo arm, SAEs were condition aggravated,
appendicitis, meniscal degeneration, and atopic dermatitis. Other
safety findings included:
Abrocitinib 200mg (N=154)
Abrocitinib 100mg (N=156)
Placebo (N=77)
Rate of Serious Adverse Events
3.2%
3.2%
1.9%
Rate of Discontinuation due to an Adverse
Event
5.8%
5.8%
9.1%
Additional Details About the JADE MONO-1 Study
The double-blind, parallel group study randomized a total of 387
subjects to abrocitinib 200mg, abrocitinib 100mg, or placebo.
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.
For additional information about the JADE MONO-1 study, please
visit https://www.clinicaltrials.gov.
Pfizer recently announced positive top-line results from the
companion Phase 3 study from the JADE program (JADE MONO-2),
suggesting similar positive safety and efficacy results. Additional
data for abrocitinib and new findings from the JADE program will be
shared in early 2020.
Phase 2b data for abrocitinib were recently published in JAMA
Dermatology.
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.2
About Atopic Dermatitis
AD is a chronic skin disease characterized by inflammation of
the skin and skin barrier defects.3,4 Lesions of AD are
characterized by erythema (redness), itching, induration
(hardening)/papulation (formulation of papules), and
oozing/crusting.3,4
AD is one of the most common, chronic, relapsing childhood
dermatoses, affecting up to 10% of adults and up to 20% of children
worldwide.5,6
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.7 JAK inhibition may offer patients with
these conditions a potential new advanced treatment option.8
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 October 12, 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 Simpson E, Sinclair R, Forman S et al. Efficacy and Safety of
Abrocitinib in Patients With Moderate-to-Severe Atopic Dermatitis:
Results From the Phase 3, JADE MONO-1 Study. Oral presentation at
the 28th Congress of the European Academy of Dermatology and
Venereology (EADV), October 9-13, 2019, Madrid, Spain 2 U.S. Food
and Drug Administration. Fact Sheet: Breakthrough Therapies at
https://www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/SignificantA...
(link is external) accessed on August 16, 2019. 3 Hanifin JM, Reed
ML. A population-based survey of eczema in the United States.
Dermatitis. 2007;18(2):82-91. 4 Bieber T. Atopic dermatitis.
Dermatology. 2012;1(3):203-217. 5 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. 6
Nutten S. Atopic dermatitis: global epidemiology and risk factors.
Ann Nutr Metab. 2015;66(suppl 1):8-16. 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20191012005003/en/
Media Contact: Steve Danehy 212-733-1538
Steven.Danehy@pfizer.com
Investor Contact: Bryan Dunn 212-733-8917
Bryan.Dunn@pfizer.com
Pfizer (NYSE:PFE)
Historical Stock Chart
From Apr 2024 to May 2024
Pfizer (NYSE:PFE)
Historical Stock Chart
From May 2023 to May 2024