- Two identical Phase 3 monotherapy studies expected to enroll a
total of approximately 800 adult and adolescent patients ages 12
and older
- Topline results from the 16-week induction period expected in
the first half of 2021
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
dosing of the first patient in a Phase 3 study evaluating the
safety and efficacy of lebrikizumab in adult and adolescent
patients ages 12 and older with moderate-to-severe atopic
dermatitis, the most common form of eczema.
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 of atopic dermatitis by promoting type 2
inflammation and mediating its effects on tissue, resulting in skin
barrier dysfunction, itch, skin thickening and infection.
“The positive results of our Phase 2b dose-ranging study suggest
specifically targeting IL-13 with lebrikizumab has the potential to
deliver a best-in-disease therapy for people living with
moderate-to-severe atopic dermatitis,” said Tom Wiggans, chairman
and chief executive officer of Dermira. “Our Phase 3 clinical
program is designed to confirm those findings and hopefully bring
an important new treatment option to the millions of people living
with this chronic and often debilitating disease. We expect to
report findings from the 16-week induction period of the
monotherapy studies in the first half of 2021.”
“The initiation of the Phase 3 study combined with the positive
results of the Phase 2b study underscore our confidence and
excitement around the potential of lebrikizumab for patients with
moderate-to-severe atopic dermatitis,” said Peter Guenter, chief
executive officer of Almirall, Dermira’s collaboration partner in
Europe. “Almirall is fully committed to this partnership and
to offering breakthrough treatments, like lebrikizumab, that have
the potential to make a meaningful difference for patients living
with severe skin conditions.”
Lebrikizumab Phase 3 Program
The lebrikizumab Phase 3 program includes two identical,
randomized, double-blind, placebo-controlled, parallel-group Phase
3 studies designed to confirm the safety and efficacy of
lebrikizumab as monotherapy in patients with moderate-to-severe
atopic dermatitis. The studies are expected to enroll a total of
approximately 800 adult and adolescent patients ages 12 years and
older with moderate-to-severe atopic dermatitis at approximately
200 sites in the United States, Europe and Asia.
Key patient inclusion criteria for the monotherapy studies
include the presence of chronic atopic dermatitis for at least one
year, an Investigator’s Global Assessment (IGA) score of 3 or 4 (on
a 5-point scale ranging from 0 to 4), an Eczema Area Severity Index
(EASI) score of 16 or greater and body surface area (BSA)
involvement of at least 10 percent at screening and baseline.
The studies will evaluate a 250 mg dose of lebrikizumab
administered by subcutaneous injection every two weeks, following a
loading dose of 500 mg administered at baseline (day 0) and week 2,
compared to placebo for 16 weeks (the induction period). Following
the end of the 16-week induction period, study patients who respond
during the induction period (as evidenced by achievement of an IGA
0/1 response, representing a reduction of 2 or more points in IGA
score from baseline to a final score of 0 (clear) or 1 (almost
clear), or an EASI-75 response, representing an improvement in EASI
score of at least 75 percent from baseline) will be re-randomized
to one of the following treatment groups for an additional 36-week
maintenance period:
- Group A: Lebrikizumab 250 mg given every two weeks;
- Group B: Lebrikizumab 250 mg given every four weeks; or
- Group C: Placebo given every two weeks.
Patients who do not achieve an IGA of 0/1 response or an EASI-75
response at week 16 and patients who do not maintain an EASI-50
response during the maintenance period will be assigned to receive
lebrikizumab 250 mg as open-label treatment every two weeks through
week 52.
The primary efficacy endpoint of the studies is the percentage
of patients with an IGA 0/1 response from baseline to week 16.
Key secondary efficacy endpoints that will be evaluated during
the 16-week induction period include: the percentage of patients
achieving EASI-75; the percentage of patients achieving EASI-90;
the percentage of patients with a pruritus (itch) numerical rating
(NRS) score of at least 4 at baseline who achieve a reduction of at
least 4 points; percentage changes in pruritus and sleep-loss
scores; and change in BSA.
The company expects to report topline findings from the 16-week
induction period in the first half of 2021. In addition to the two
monotherapy studies, the company plans to include a study in the
Phase 3 program that evaluates lebrikizumab when used in
combination with topical corticosteroids. The impact of
lebrikizumab treatment on quality of life will also be assessed
across a number of additional measures.
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 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 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 and
Almirall Collaboration
Agreement
In February 2019, Almirall, S.A. (BME: ALM) and Dermira entered
into an option and license agreement under which Almirall acquired
an option to obtain exclusive license rights to develop
lebrikizumab for the treatment or prevention of dermatology
indications, including but not limited to atopic dermatitis, and
commercialize lebrikizumab for the treatment or prevention of all
indications in Europe. Almirall exercised the option in June 2019.
Under the terms of the agreement, Dermira received payments
relating to the option and option exercise and is entitled to
receive additional payments upon the achievement of certain
development, regulatory and sales milestones, including in
connection with the initiation of certain Phase 3 clinical studies,
as well as royalty payments representing percentages of net sales
of lebrikizumab in Europe.
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 press 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 press release
contains forward-looking statements that involve substantial risks
and uncertainties, including statements with respect to: Dermira’s
goal of building a leading medical dermatology company dedicated to
delivering differentiated, new therapies to the millions of
patients living with chronic skin conditions; the design,
description of and enrollment expectations for Dermira’s Phase 3
program evaluating lebrikizumab for moderate-to-severe atopic
dermatitis; the successful completion of, and timing expectations
for the receipt and announcement of topline data from, the Phase 3
program; the potential of lebrikizumab to deliver a best-in-disease
therapy for people living with moderate-to-severe atopic
dermatitis; Dermira’s plan to include a study in the Phase 3
program that evaluates lebrikizumab when used in combination with
topical corticosteroids; and the potential milestone payments and
royalties payable to Dermira under the terms of the option and
license agreement entered into between Almirall and Dermira. 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 clinical
trials; 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; Dermira’s
ability to develop and maintain collaborations and license products
and intellectual property; Dermira’s ability to attract and retain
key employees; Dermira’s ability to obtain necessary additional
capital; market acceptance of Dermira’s current and potential
products; 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 press 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/20191009005218/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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