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Pfizer Presents Positive Phase 2 Data in Alopecia Areata During Late-Breaker Session at the 27th European Academy of Dermatology and Venereology (EADV) Congress

Saturday, September 15, 2018 - 2:00am
EDT

Pfizer Inc. (NYSE:PFE) today announced results from its Phase 2a study
of PF-06651600, an oral Janus kinase (JAK) 3 inhibitor, and PF-06700841,
a tyrosine kinase (TYK) 2/JAK1 inhibitor, compared to placebo, in
patients with moderate to severe alopecia areata (AA), an autoimmune
disease characterized by hair loss and often associated with profound
psychological consequences. Both JAK inhibitors met the primary efficacy
endpoint in improving hair regrowth on the scalp relative to baseline at
week 24 (33.6 points and 49.5 points for JAK3 and TYK2/JAK1,
respectively) as measured by the Severity of Alopecia Tool (SALT) score
(100 point scale). The findings were presented during a Late-Breaking
News session at the 27th European Academy of Dermatology and Venereology
(EADV) Congress in Paris, France.

“We are pleased with these results and excited by the potential of
kinase inhibition as a new therapeutic target for patients living with
alopecia areata. This is the first well-controlled study of oral JAK
inhibitors in alopecia areata, helping enhance our understanding of this
disease with significant unmet need and advance the science of kinase
inhibition,” said Michael Vincent, M.D, Ph.D., Senior Vice President and
Chief Scientific Officer, Pfizer Inflammation and Immunology.

Based on the totality of the data and the emerging clinical profiles,
the investigational JAK3 inhibitor, which was recently granted
Breakthrough Therapy designation from FDA for alopecia areata, is
advancing to the next phase of development for moderate to severe AA and
will continue to be evaluated for rheumatoid arthritis (RA), Crohn’s
disease (CD) and ulcerative colitis (UC). PF-06700841 will continue to
be evaluated for psoriasis (PsO), CD and UC.

“People living with alopecia areata face a difficult journey as there
are currently no approved treatments,” said study investigator Rodney
Sinclair, MD, Sinclair Dermatology, Melbourne, Victoria, Australia. “The
results seen with these JAK inhibitors are very encouraging for me as a
clinician as they signal a potential new way to think about the
treatment of alopecia, which may bring hope for patients with this
distressing condition.”

About the Study

This Phase 2a, randomized, double-blind, multicenter study evaluates the
efficacy, safety, and tolerability of PF-06651600 and PF-06700841
compared to placebo in patients with moderate to severe AA. Patients
were randomized 1:1:1 to receive: PF-06651600 (200 mg once daily [QD]
for 4 weeks, followed by 50 mg QD for 20 weeks), or PF-06700841 (60 mg
QD for 4 weeks, followed by 30 mg QD for 20 weeks), or placebo.

The study found that the placebo-adjusted mean (95% CI) in SALT change
from baseline scores at Week 24 were 33.6 points (21.4, 45.7),
(P PF-06700841, with statistically significant separation from placebo
occurring as early as Week 6 and Week 4, respectively.

In addition to meeting the primary efficacy endpoint, the
investigational candidates also met all secondary endpoints in this
study.

Overall, adverse event (AE) rates were comparable between treatment
groups. The most common adverse events seen in the study were in the
infections, gastrointestinal and skin/subcutaneous tissue categories.
There were no cases of herpes zoster reactivation.

About Alopecia Areata

Alopecia areata (AA) is an autoimmune disease, characterized by hair
loss, often patchy, on the scalp, face, or body.1,2 People
suffering from AA experience symptoms when immune cells attack healthy
hair follicles, causing the hair to fall out, often starting with
smooth, round patches.1,2 The mean age of onset is between 25
and 35, but it can also impact children and adolescents, and is seen in
both sexes and all ethnicities.1,2 More than half of patients
with AA experience poor health-related quality of life and, as a result,
the condition may lead to serious psychological consequences, including
high levels of depression and anxiety.1

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.1
JAK inhibition offers the potential for new advanced treatment options
for these conditions through unique and targeted selectivity.

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. Pfizer has the following kinase inhibitors in trials
across multiple indications:

  • PF-06651600: A JAK 3 inhibitor for RA arthritis, CD and UC;
    PF-06651600 received Breakthrough Therapy designation from the FDA for
    the treatment of patients with AA
  • PF-06700841: A TYK2/JAK1 inhibitor under investigation for the
    treatment of PsO, CD and UC
  • PF-04965842: A selective JAK1 inhibitor in Phase 3 clinical trials for
    the treatment of atopic dermatitis(AD)2; PF-04965842
    received Breakthrough Therapy designation from the FDA for the
    treatment of patients with moderate to severe AD
  • PF-06650833: An interleukin-1 receptor associated kinase 4 (IRAK4)
    inhibitor under investigation for the treatment of RA
  • PF-06826647: A TYK2 inhibitor under investigation for the treatment of
    PsO and inflammatory bowel disease

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
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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 September 15, 2018. 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-06651600
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-06651600 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-06651600 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-06651600 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, 2017 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 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

2
J Med Chem. 2018 Feb 8;61(3):1130-1152. doi:
10.1021/acs.jmedchem.7b01598. Epub 2018 Jan 23.



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Pfizer Inc.
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Dervila Keane
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or
Investors:
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