NEW YORK--(BUSINESS WIRE)--
Pfizer Inc. (NYSE: PFE) announced today the initiation of a Phase 2b/3
clinical trial for its oral JAK3 inhibitor, PF-06651600, for the
treatment of patients with moderate to severe alopecia areata, a chronic
autoimmune skin disease that causes hair loss on the scalp, face, or
body, and currently has no approved therapies.1,2
“We are proud to start this global pivotal Phase 2b/3 trial for
PF-06651600 in patients with alopecia areata. We hope this potential
treatment will be able to help patients who currently have limited
treatment options,” said Michael Corbo, Chief Development Officer,
Inflammation & Immunology, Pfizer Global Product Development. “Including
our JAK3 program, Pfizer has several selective kinase programs in the
clinic with studies spanning across rheumatology, gastrointestinal
disorders, and medical dermatology, where we aspire to deliver
potentially transformative medicines to those living with chronic
autoimmune and inflammatory conditions.”
Positive Phase 2a data for PF-06651600 was recently presented as a late-breaker
at the 27th European Academy of Dermatology and Venerology
(EADV). The study met the primary efficacy endpoint in improving hair
regrowth on the scalp relative to baseline at week 24 as measured by the
Severity of Alopecia Tool (SALT) score (100 point scale). In addition to
meeting the primary efficacy endpoint, the investigational candidate
also met all secondary endpoints in the study. Overall, adverse event
(AE) rates were comparable between treatment groups. The most common AEs
seen in the study were in the infections, gastrointestinal and
skin/subcutaneous tissue categories. There were no cases of herpes
zoster reactivation.
Based on the totality of the data and the emerging clinical profile,
PF-06651600 was granted Breakthrough Therapy designation from U.S. FDA
for the treatment of alopecia areata in
September 2018. PF-06651600 will also continue to be evaluated for
rheumatoid arthritis, Crohn’s disease and ulcerative colitis.
About the PF-06651600 Phase 2b/3 Program
The pivotal trial will enroll an estimated 660 patients and will be a
double-blind, placebo-controlled, dose-ranging study to evaluate the
safety and effectiveness of PF-06651600 in adults and adolescents (12
years and older) who have 50% or greater scalp hair loss. More on the
study can be found on www.clinicaltrials.gov
under the identifier NCT03732807.
About Alopecia Areata
Alopecia areata is an autoimmune disease, characterized by hair loss,
often patchy, on the scalp, face, or body.1,2 People
suffering from alopecia areata 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 alopecia areata 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
About PF-06651600 and 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.3
JAK inhibition may offer patients with these conditions a potential new
advanced treatment option.4
PF-06651600 is an oral JAK3 inhibitor that is also under investigation
for the treatment of rheumatoid arthritis, Crohn’s disease and
ulcerative colitis.4
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. In addition to PF-06651600, Pfizer has a number of kinase
inhibitors in clinical trials across multiple indications, including:
-
PF-04965842: An investigational selective JAK1 inhibitor in Phase 3
clinical trials for the treatment of atopic dermatitis(AD)5;
PF-04965842 received Breakthrough Therapy designation from the FDA for
the treatment of patients with moderate-to-severe AD in February 2018
-
PF-06700841: A tyrosine kinase 2(TYK2)/JAK1 inhibitor under
investigation for the treatment of psoriasis, Crohn’s disease,
ulcerative colitis and alopecia areata
-
PF-06650833: An interleukin-1 receptor associated kinase 4 (IRAK4)
inhibitor under investigation for the treatment of rheumatoid arthritis
-
PF-06826647: A TYK2 inhibitor under investigation for the treatment of
psoriasis and inflammatory bowel disease (IBD)
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 important to
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addition, to learn more, please visit us on www.pfizer.com
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DISCLOSURE NOTICE: The information contained in this release
is as of January 3, 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 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-06651600or 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-06651600or 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-06651600or
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 Villasante Fricke AC,
Miteva M. Epidemiology and burden of alopecia areata: a systematic
review. Clinical, Cosmetic and Investigational Dermatology.
2015;8:397-403. doi:10.2147/CCID.S53985.
2 Pratt CH,
King LE, Messenger AG, Christiano AM, Sundberg JP. Alopecia areata. Nature
reviews Disease primers. 2017;3:17011. doi:10.1038/nrdp.2017.11.
3
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
4
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.
5 J
Med Chem. 2018 Feb 8;61(3):1130-1152. doi: 10.1021/acs.jmedchem.7b01598.
Epub 2018 Jan 23.
View source version on businesswire.com:
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Media: Neha Wadhwa
212-733-2835
Neha.Wadhwa@pfizer.com
Investors: Bryan Dunn
212-733-8917
Bryan.Dunn@pfizer.com
Source: Pfizer Inc.