Market Overview

Pfizer Initiates Phase 3 Program for PF-04965842, a JAK1 Inhibitor in Development for Moderate-to-Severe Atopic Dermatitis

  • Global program to commence with pivotal study B7451012 in North
    America, Australia and Europe; broader regional rollout in 2018

Pfizer Inc. (NYSE:PFE) today announced the initiation of a Phase 3
program for its once-daily Janus kinase 1 (JAK1) inhibitor PF-04965842,
to evaluate the efficacy and safety of PF-04965842 for the treatment of
moderate-to-severe atopic dermatitis (AD). This is the first trial in
the JAK1 Atopic
Dermatitis Efficacy
and safety (JADE) global development program.

"By initiating this Phase 3 program in atopic dermatitis, we hope to
provide a new potential treatment option for people suffering with this
condition," said Michael Corbo, Chief Development Officer, Inflammation
& Immunology, Pfizer Global Product Development. "Pfizer continues to
build a leadership position in inflammation and immunology research with
the advancement of this important, Pfizer-discovered investigational
oral JAK1 inhibitor."

About the Phase 3 Trial B7451012

This Phase 3 trial is a randomized, double-blind, placebo-controlled,
parallel-group study designed to evaluate the efficacy and safety of
PF-04965842 in 375 patients 12 years and older with moderate-to-severe
AD. Trial participants will be randomly assigned to receive 200 mg or
100 mg once daily or placebo.

The primary endpoints are the proportion of patients achieving an
Investigator Global Assessment (IGA) score of 0/1 and ≥2 point
improvement, and the proportion of patients with at least a 75% or
greater change from baseline in their Eczema Area and Severity Index
(EASI) score. Key secondary endpoints include the pruritus numerical
rating scale, the Pruritus and Symptoms Assessment for Atopic Dermatitis
(PSAAD) electronic diary and safety measures such as the incidence of
treatment emergent adverse events and laboratory abnormalities. The
treatment duration will be 12 weeks, the same duration as the Phase 2b
study B7451006, with a 4 week safety follow-up period or the option to
enter a long-term extension study (B7451015) at Week 12. More on the
study can be found on
under the identifier NCT03349060.

The design of the Phase 3 trial is based on the Phase 2 results that
were presented at the 26th Congress of the European Academy
of Dermatology and Venereology in September 2017.

About Atopic Dermatitis

Atopic dermatitis, also commonly called atopic eczema, is inflammation
of the skin and characterized by erythema (redness), itching (pruritus),
induration (hardening)/papulation (formation of papules), and

About Pfizer's Kinase Inhibitor Leadership

PF-04965842 is an oral small molecule that selectively inhibits Janus
kinase 1 (JAK1). Inhibition of JAK1 modulates multiple cytokines
involved in pathophysiology of AD including interleukin (IL)-4, IL-13,
IL-31 and interferon gamma (IFNɣ).

"We look forward to advancing other kinase inhibitors currently in
mid-stage research for other diseases such as alopecia, psoriasis,
inflammatory bowel disease, and rheumatoid arthritis," said Michael
Vincent, M.D, Ph.D., Senior Vice President and Chief Scientific Officer
of Inflammation and Immunology Research at Pfizer.

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 advancing several investigational
programs with novel selectivity profiles, which, if successful, could
potentially deliver transformative therapies for patients. Pfizer has
three additional kinase inhibitors in Phase 2 development across
multiple indications:

  • PF-06651600: A JAK3 inhibitor under investigation for the treatment of
    rheumatoid arthritis, ulcerative colitis and alopecia areata
  • PF-06700841: A tyrosine kinase 2 (TYK2)/JAK1 inhibitor under
    investigation for the treatment of psoriasis, ulcerative colitis and
    alopecia areata
  • PF-06650833: An interleukin-1 receptor-associated kinase 4 (IRAK4)
    inhibitor under investigation for the treatment of rheumatoid arthritis

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
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DISCLOSURE NOTICE: The information contained in this release
is as of December 12, 2017. 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 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 trial commencement and completion dates and regulatory
submission dates, as well as the possibility of unfavorable clinical
trial results, including unfavorable new clinical data and additional
analyses of existing data; risks associated with preliminary data; the
risk that clinical trial data are subject to differing interpretations,
and, even when we view data as sufficient to support the safety and/or
effectiveness of a product candidate, regulatory authorities may not
share our views and may require additional data or may deny approval
altogether; 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 PF-04965842 or any other investigational kinase inhibitor
therapies; whether and when any such applications may be approved by
regulatory authorities, which will depend on the assessment by such
regulatory authorities of the benefit-risk profile suggested by the
totality of the efficacy and safety information submitted, and, if
approved, whether PF-04965842 or any such other investigational kinase
inhibitor therapies will be commercially successful; decisions by
regulatory authorities regarding labeling, safety and other matters that
could affect the availability or commercial potential of PF-04965842 or
any other investigational kinase inhibitor therapies; and competitive

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, 2016 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 and

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