- Detailed primary results of lebrikizumab
Phase 2b study to be presented at the Fall Clinical Dermatology
Conference - Data reflect potential of lebrikizumab to offer
best-in-disease combination of safety, efficacy, tolerability,
convenience and ease of use - Conference call and webcast to be
held on October 17 to discuss data and provide overview of Phase 3
clinical development program
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
detailed primary results of its Phase 2b study of lebrikizumab in
patients with moderate-to-severe atopic dermatitis will be reported
at the 39th Annual Fall Clinical Dermatology Conference in Las
Vegas, NV, October 17-20, 2019. In addition, the company will host
a conference call and webcast on October 17, 2019, during which Dr.
April W. Armstrong will discuss the data presented and company
management will provide an overview of the lebrikizumab Phase 3
clinical development program.
“As a prevalent, debilitating condition with limited treatment
options, moderate-to-severe atopic dermatitis remains a
significant, unmet medical need,” said Tom Wiggans, chairman and
chief executive officer at Dermira. “This year, we have made
tremendous strides in our commitment to help address this need,
producing Phase 2b results that support our belief that
lebrikizumab can be a best-in-disease treatment option for the more
than 10 million Americans who suffer with this condition, and
rapidly advancing the program into Phase 3 development. We look
forward to sharing more details about these exciting results and
the program we have designed to deliver what we believe will be an
important, new therapy to atopic dermatitis patients and the
healthcare professionals who care for them.”
Fall Clinical Dermatology Conference Poster
Presentation
The poster, described below, will be available for viewing on
Friday and Saturday during the meeting. Dermira expects these data
will also be included and discussed during atopic dermatitis
presentations during the conference.
Title:
Lebrikizumab, a High Affinity IL-13
Inhibitor, Improves Clinical Manifestations in Moderate-to-Severe
Atopic Dermatitis: Primary Results from a Randomized,
Double-Blinded, Placebo-Controlled, Dose-Ranging, Phase 2b
Study
Date and time:
Friday, October 18 from 7:00 a.m. to 4:30
p.m. PT
Saturday, October 19 from 7:00 a.m. to
1:00 p.m. PT
Location:
Poster Gallery located between the Lafite
and Latour Ballrooms, Wynn Las Vegas Hotel
Lebrikizumab Program Update Webcast
On October 17, 2019 at 1:45 p.m. PT, April W. Armstrong, MD,
MPH, professor of dermatology and associate dean of clinical
research at the University of Southern California Keck School of
Medicine, and an investigator in the lebrikizumab study, will
discuss the Phase 2b data presented during the Fall Clinical
Dermatology Conference. Dermira management will also provide an
overview of the lebrikizumab Phase 3 development program, the
initiation of which was previously announced. The live audio
webcast and an archive of the presentation will be available in the
investor relations section of Dermira’s website at:
https://investor.dermira.com.
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 broad spectrum of signs and
symptoms that includes skin rashes that often cover much of the
body, as well as intense, persistent itching, which together can
have a significant 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 an investigational novel, 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 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 currently evaluating lebrikizumab in a
Phase 3 clinical development program for the treatment of
moderate-to-severe atopic dermatitis (a severe form of eczema) and
also 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 potential of
lebrikizumab to offer best-in-disease combination of safety,
efficacy, tolerability, convenience and ease of use and to be a
best-in-disease treatment option for the more than 10 million
Americans who suffer from atopic dermatitis; Dermira’s plans to
rapidly advance the lebrikizumab program through Phase 3
development; and Dermira’s belief that the design of its
lebrikizumab Phase 3 program will deliver an important, new therapy
to atopic dermatitis patients and the healthcare professionals who
care for them. 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 Dermira’s dependence on third-party clinical research
organizations, manufacturers, suppliers and distributors; the
design and implementation of Dermira’s clinical trials; the
outcomes of future meetings with regulatory agencies; 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/20191010005269/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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