- New findings in human sensory neurons highlight role of IL-13
in amplifying itch and lebrikizumab’s role in inhibiting itch
signals in atopic dermatitis
- Lebrikizumab Phase 3 program is currently enrolling adult and
adolescent patients with moderate-to-severe atopic dermatitis
Dermira, Inc. (NASDAQ: DERM), a biopharmaceutical company
dedicated to bringing biotech ingenuity to medical dermatology by
delivering differentiated, new therapies to the millions of
patients living with chronic skin conditions, today announced that
new scientific findings highlighting the role of interleukin-13
(IL-13) in amplifying itch and the role lebrikizumab plays in
reducing itch, will be presented at the 10th World Congress on Itch
taking place November 17-19 in Sydney, Australia.
Itch is defined as an unpleasant sensation causing the desire to
scratch the surface of the skin. Chronic itch affects approximately
one-fifth of the global population and can have a significant
impact on a person’s quality of life. Itch is often associated with
sleep disorders, depression and anxiety and is cited as one of the
most burdensome aspects of atopic dermatitis, as underscored during
a recent Patient-Focused Drug Development meeting.
IL-13 is believed to be a central pathogenic mediator that
drives multiple aspects of the pathophysiology underlying the range
of signs and symptoms of atopic dermatitis by promoting type 2
inflammation and mediating its effects on tissue, resulting in skin
barrier dysfunction, itch, skin thickening and infection.
Key Research Findings
In laboratory experiments, cultured human sensory neurons were
stimulated with IL-13 and subsequently introduced to several common
itch-inducing agents (pruritogens), including histamine, serotonin
and BAM8-22. The experiments demonstrated that IL-13 directly
interacts with human sensory neurons, enhancing the itch induced by
these itch-inducing agents.
When lebrikizumab was introduced, it significantly inhibited
these potentiated itch signals to known pruritogens, demonstrating
that lebrikizumab has the potential to block enhanced itch signals
in inflammatory skin conditions such as atopic dermatitis. This
finding supports the results observed in Dermira’s Phase 2b
dose-ranging study evaluating lebrikizumab in patients with
moderate-to-severe atopic dermatitis, who reported improvements in
itch symptoms as early as day two of treatment.
The findings will be submitted for publication in a
peer-reviewed journal.
“People suffering from chronic itch associated with a host of
dermatologic diseases often cite it as the most debilitating
symptom,” said Luis Peña, chief development officer of Dermira. “We
believe these findings support our understanding of the role of
lebrikizumab in reducing itch, helping to explain the improvement
in itch observed in atopic dermatitis patients treated with the
investigational therapy in our Phase 2b study.”
Lebrikizumab is a novel, investigational, monoclonal antibody
designed to bind IL-13 with very high affinity, specifically
preventing the formation of the IL-13Rα1/IL-4Rα heterodimer complex
and subsequent signaling, thereby inhibiting the biological effects
of IL-13 in a targeted and efficient fashion.
The findings on itch will be presented by Ferda Cevikbas, Ph.D.,
director of research at Dermira, on November 19, 2019 during a
session titled, Concurrent Session 2: New receptors, channels and
pathways for itch. Dr. Cevikbas is also serving as co-chair of the
session.
Dr. Cevikbas is a noted expert in the pathophysiology of itch,
having spent much of her career at the University of California,
San Francisco, where she studied the differences and similarities
between itch and pain. Prior to joining Dermira, she worked with a
team of researchers at a biotechnology company exploring the
mechanism of action for research compounds in inflammation and
itch. Dr. Cevikbas is trained in dermatology and neuroscience.
“IL-13 has long been viewed as an important target in atopic
dermatitis,” said Dr. Cevikbas. “For the first time, IL-13 has been
investigated in translational neuroscience studies in human sensory
neurons to understand its role in chronic itch and the ability of
lebrikizumab to block the effects of neuroactive IL-13. This
translational work will inform future research and enhance our
understanding of chronic itch in atopic dermatitis.”
About Atopic Dermatitis
Atopic dermatitis is the most common and severe form of eczema,
a chronic inflammatory condition that can present as early as
childhood and continue into adulthood. A moderate-to-severe form of
the disease is characterized by a range of signs and symptoms,
including rashes on the skin that often cover much of the body, as
well as intense, persistent itching. The condition can have a
negative impact on patients’ mental and physical functioning,
limiting their daily activities and health-related quality of life.
Patients with moderate-to-severe atopic dermatitis have reported a
larger impact on quality of life than patients with psoriasis.
About Lebrikizumab
Lebrikizumab is a novel, investigational, monoclonal antibody
designed to bind IL-13 with very high affinity, specifically
preventing the formation of the IL-13Rα1/IL-4Rα heterodimer complex
and subsequent signaling, thereby inhibiting the biological effects
of IL-13 in a targeted and efficient fashion. IL-13 is believed to
be a central pathogenic mediator that drives multiple aspects of
the pathophysiology underlying the range of signs and symptoms of
atopic dermatitis by promoting type 2 inflammation and mediating
its effects on tissue, resulting in skin barrier dysfunction, itch,
skin thickening and infection.
About Dermira
Dermira is a biopharmaceutical company dedicated to bringing
biotech ingenuity to medical dermatology by delivering
differentiated, new therapies to the millions of patients living
with chronic skin conditions. Dermira is committed to understanding
the needs of both patients and physicians and using its insight to
identify, develop and commercialize leading-edge medical
dermatology products. The company’s approved treatment, QBREXZA®
(glycopyrronium) cloth, is indicated for pediatric and adult
patients (ages 9 and older) with primary axillary hyperhidrosis
(excessive underarm sweating). Please see the QBREXZA prescribing
information. Dermira is evaluating lebrikizumab in a Phase 3
clinical development program for the treatment of
moderate-to-severe atopic dermatitis (a severe form of eczema) and
has early-stage research and development programs in other areas of
dermatology. Dermira is headquartered in Menlo Park, Calif. For
more information, please visit http://www.dermira.com. Follow
Dermira on Twitter, LinkedIn and Instagram.
In addition to filings with the Securities and Exchange
Commission (SEC), press releases, public conference calls and
webcasts, Dermira uses its website (www.dermira.com), LinkedIn page
(https://www.linkedin.com/company/dermira-inc-), corporate
Instagram account (https://www.instagram.com/dermira_inc/) and
corporate Twitter account (@DermiraInc) as channels of distribution
of information about its company, product candidates, planned
financial and other announcements, attendance at upcoming investor
and industry conferences and other matters. Such information may be
deemed material information and Dermira may use these channels to
comply with its disclosure obligations under Regulation FD.
Therefore, investors should monitor Dermira’s website, LinkedIn
page, Instagram and Twitter accounts in addition to following its
SEC filings, news releases, public conference calls and
webcasts.
Forward-Looking Statements
The information in this news release contains forward-looking
statements and information within the meaning of Section 27A of the
Securities Act of 1933, as amended, and Section 21E of the
Securities Exchange Act of 1934, as amended, which are subject to
the “safe harbor” created by those sections. This news release
contains forward-looking statements that involve substantial risks
and uncertainties, including statements with respect to Dermira’s
goal of bringing biotech ingenuity to medical dermatology by
delivering differentiated, new therapies to the millions of
patients living with chronic skin conditions; the belief, based on
results of the scientific experiments, that lebrikizumab plays a
role in reducing itch; and that lebrikizumab has the potential to
block enhanced itch signals in inflammatory skin conditions such as
atopic dermatitis. These statements deal with future events and
involve known and unknown risks, uncertainties and other factors
that may cause actual results, performance or achievements to be
materially different from the information expressed or implied by
these forward-looking statements. Factors that could cause actual
results to differ materially include risks and uncertainties such
as those relating to the design, implementation and outcomes of
Dermira’s Phase 3 clinical trials evaluating lebrikizumab in adult
and adolescent patients with moderate-to-severe atopic dermatitis;
the impact of competitive clinical trials, products and therapies;
Dermira’s dependence on third-party clinical research
organizations, manufacturers, suppliers and distributors; the
outcomes of future meetings with regulatory agencies; market
acceptance of Dermira’s current and potential products; Dermira’s
ability to attract and retain key employees; Dermira’s ability to
manage the growth and complexity of its organization; Dermira’s
ability to maintain, protect and enhance its intellectual property;
and Dermira’s ability to continue to stay in compliance with its
material contractual obligations, applicable laws and regulations.
You should refer to the section entitled “Risk Factors” set forth
in Dermira’s Annual Report on Form 10-K, Dermira’s Quarterly
Reports on Form 10-Q and other filings Dermira makes with the SEC
from time to time for a discussion of important factors that may
cause actual results to differ materially from those expressed or
implied by Dermira’s forward-looking statements. Furthermore, such
forward-looking statements speak only as of the date of this news
release. Dermira undertakes no obligation to publicly update any
forward-looking statements or reasons why actual results might
differ, whether as a result of new information, future events or
otherwise, except as required by law.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20191114005651/en/
Media: Erica Jefferson Vice President, Corporate Communications
650-421-7216 media@dermira.com
Erin Murphy Director, Corporate Communications 650-422-7746
erin.murphy@dermira.com
Investors: Andrew Guggenhime Chief Financial Officer
650-421-7200 investor@dermira.com
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