Pfizer Initiates Phase 3 Program for PF-04965842, a JAK1 Inhibitor in Development for Moderate-to-Severe Atopic Dermatitis
December 14 2017 - 7:30AM
Business Wire
- 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 www.clinicaltrials.gov 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 oozing/crusting.
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 more than 150 years, we have worked to make a difference for
all who rely on us. We routinely post information that may be
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addition, to learn more, please visit us on www.pfizer.com and
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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 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, 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 www.sec.gov and www.pfizer.com.
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Pfizer Inc.Media:Neha Wadhwa,
212-733-2835Neha.Wadhwa@pfizer.comorInvestors:Ryan Crowe,
212-733-8160Ryan.crowe@pfizer.com
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