- Lebrikizumab demonstrated dose-dependent improvements across
endpoints spanning the range of atopic dermatitis signs and
symptoms, including skin lesions and pruritus, when administered
once every two or four weeks - Improvement in pruritus was reported
as early as second day of treatment - Consistent with prior
experience, lebrikizumab was well-tolerated, with low rates of
conjunctivitis - Conference call and webcast today at 1:45 p.m. PT
/ 4:45 p.m. ET
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 from its Phase 2b dose-ranging study of
lebrikizumab are being presented during the 39th Annual Fall
Clinical Dermatology Conference in Las Vegas, NV. Lebrikizumab is
currently being evaluated in a Phase 3 program in adult and
adolescent patients with moderate-to-severe atopic dermatitis.
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.
“These results are encouraging and suggest that lebrikizumab has
the potential to advance the standard of care for patients with
moderate-to-severe atopic dermatitis by delivering improvements in
efficacy, tolerability and convenience relative to available
therapies,” said April W. Armstrong, M.D., 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. “In this study,
lebrikizumab administered once every two or four weeks demonstrated
robust, broad efficacy with a safety profile consistent with the
substantial prior experience with this and other biologics
targeting the IL-4/-13 pathway. Among these encouraging results, I
am particularly excited about the impact of lebrikizumab on itch,
which is one of the most burdensome symptoms for many atopic
dermatitis patients.”
About the Lebrikizumab Phase 2b Study
The randomized, double-blind, placebo-controlled, parallel-group
Phase 2b study was designed to evaluate the safety and efficacy of
lebrikizumab as monotherapy compared with placebo and establish a
dosing regimen for the Phase 3 program in patients with
moderate-to-severe atopic dermatitis. The study enrolled 280
patients ages 18 years and older with moderate-to-severe atopic
dermatitis at 57 sites in the United States. Three different
lebrikizumab treatment dosing arms were evaluated, compared to a
placebo arm, with patients randomized in a 3:3:3:2 fashion as
follows:
- Group 1: A loading dose of 250 mg of lebrikizumab at baseline
(day 0), followed by 125 mg of lebrikizumab every four weeks.
- Group 2: A loading dose of 500 mg of lebrikizumab at baseline
(day 0), followed by 250 mg of lebrikizumab every four weeks.
- Group 3: A loading dose of 500 mg of lebrikizumab at baseline
(day 0) and week 2, followed by 250 mg of lebrikizumab every two
weeks.
- Group 4: Placebo at baseline (day 0) and every two weeks
thereafter.
The inclusion criteria for patients enrolled in this study
included the presence of chronic atopic dermatitis for at least one
year, an Eczema Area and Severity Index (EASI) score of 16 or
greater, an Investigator’s Global Assessment (IGA) score of 3 or 4
(on a 5-point scale ranging from 0 to 4) and body surface area
(BSA) involvement of at least 10 percent at screening and
baseline.
The primary endpoint of the study was the percent change in EASI
from baseline to week 16. Secondary endpoints that were evaluated
during the 16-week treatment period included: the proportion of
patients with a 75 percent improvement from baseline in EASI score
(EASI-75); the proportion of patients with a reduction of 2 or more
points in IGA score from baseline to a final score of 0 (clear) or
1 (almost clear) (IGA0/1); the proportion of patients achieving
EASI-50 and EASI-90; changes in pruritus (itch) and sleep loss
scores from baseline, each scored using a numerical rating scale
(NRS); and the proportion of patients with an improvement in
pruritus NRS score (on an 11-point scale) of at least 4 points from
baseline.
Newly Presented Lebrikizumab Phase 2b Study Results Presented
at Fall Clinical Dermatology Conference
Initial topline findings from the Phase 2b study were previously
announced in March 2019, showing that across all doses evaluated,
lebrikizumab demonstrated dose-dependent and statistically
significant improvements in the primary endpoint, the mean percent
change in EASI score from baseline to week 16.
The data being presented highlight secondary endpoints assessing
measures spanning the range of signs and symptoms of atopic
dermatitis, including skin lesions (the proportions of patients
achieving EASI-50, EASI-75, EASI-90 and IGA0/1) and pruritus (mean
percent change in pruritus NRS score and the proportion of patients
achieving an improvement of at least 4 points in pruritus NRS
score) over the 16-week treatment period. Key findings include the
following:
Skin Lesions
- A response was observed as early as the first on-treatment
visit at week 4 for all atopic dermatitis severity scores.
Lebrikizumab demonstrated a dose-dependent response across each of
the EASI-50, EASI-75, EASI-90 and IGA0/1 endpoints, with marked
improvement at both the 250 mg every two weeks (Q2W) and 250 mg
every four weeks (Q4W) doses.
- A greater proportion of lebrikizumab- versus placebo-treated
patients achieved EASI-50, EASI-75, EASI-90 and IGA0/1 at week 16,
with statistically significant improvements seen with lebrikizumab
as follows:
EASI-50
EASI-75
EASI-90
IGA0/1
250 mg Q2W
81.0%***
60.6%***
44.0%***
44.6%**
250 mg Q4W
77.0%**
56.1%**
36.1%**
33.7%*
125 mg Q4W
66.4%
43.3%
26.1%
26.6%
Placebo
45.8%
24.3%
11.4%
15.3%
*p<0.05, **p<0.01, and ***p<0.001
versus placebo
Pruritus (Itch)
- Dose-dependent improvements in pruritus, as reported by
patients, were observed as early as day 2 and continued through
week 16.
- By week 16, patients receiving lebrikizumab at doses of 125 mg
Q4W, 250 mg Q4W and 250 mg Q2W reported mean improvements in
pruritus NRS score of 36.9% (p<0.01), 48.6% (p<0.001) and
61.8% (p<0.001), compared to a mean worsening of 6.8% in
patients receiving placebo.
- The proportion of patients reporting an improvement of at least
4 points in pruritus NRS score was highest in the 250 mg Q2W group,
reaching 51.9% by week 4 and at week 16, 70.0% (p<0.001 vs.
placebo).
As expected, based on prior experience, lebrikizumab was
generally well-tolerated, with a safety profile consistent with
that observed in prior studies in more than 4,000 patients. Adverse
events observed in lebrikizumab-treated patients were primarily
mild to moderate in severity and infrequently led to treatment
discontinuation. The most common adverse events reported across the
lebrikizumab 250mg Q2W, 250mg Q4W and 125mg Q4W dosing arms were
upper respiratory tract infection (2.7%, 11.3% and 8.2%,
respectively, vs. 5.8% for placebo), nasopharyngitis (12.0%, 2.5%
and 5.5%, respectively, vs. 3.8% for placebo), headache (5.3%, 1.3%
and 4.1%, respectively, vs. 5.8% for placebo) and injection site
pain (5.3%, 3.8% and 0.0%, respectively, vs. 1.9% for placebo).
Rates of herpes viral infections (which includes oral herpes,
herpes zoster, genital herpes, herpes simplex, and eczema
herpeticum) were 2.7%, 5.0% and 2.7%, respectively, vs. 3.8% for
placebo) and conjunctivitis (2.7%, 3.8% and 1.4%, respectively, vs.
0.0% for placebo) were low. Across all studies of lebrikizumab
conducted to date in atopic dermatitis, conjunctivitis has been
reported at low rates similar to those in patients receiving
placebo.
“Our goal with lebrikizumab is to develop a best-in-disease
therapy for patients with moderate-to-severe atopic dermatitis that
not only improves the severity of disease, but that is also safe
and convenient,” said Eugene A. Bauer, M.D., chief medical officer
at Dermira and a dermatologist. “These results support our belief
that specifically targeting IL-13 with lebrikizumab has the
potential to deliver on all of these objectives and thus help
address the substantial unmet medical need in this prevalent,
debilitating condition.”
Based on the Phase 2b study results, Dermira recently announced
the initiation of a Phase 3 clinical development program to further
evaluate lebrikizumab in adult and adolescent patients with
moderate-to-severe atopic dermatitis.
Lebrikizumab Program Update Webcast
Dermira will host a webcast and conference call today beginning
at 1:45 p.m. Pacific Time / 4:45 p.m. Eastern Time. 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 Phase 2b
study, will discuss the data presented during the Fall Clinical
Dermatology Conference. Dermira management will also provide an
overview of the lebrikizumab Phase 3 development program.
Conference Call Information: Toll-free: (866) 211-3117
International: (647) 689-6606 Conference ID: 3193467
Webcast information: Visit http://investor.dermira.com.
A webcast replay will be available on the Dermira website for 30
days.
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 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; that lebrikizumab has
the potential to advance the standard of care for patients with
moderate-to-severe atopic dermatitis by delivering improvements in
efficacy, tolerability and convenience relative to available
therapies; Dermira’s goal to develop lebrikizumab as a
best-in-disease therapy for patients with moderate-to-severe atopic
dermatitis that not only improves the severity of disease, but that
is also safe and convenient; and the belief that specifically
targeting IL-13 with lebrikizumab has the potential to address the
substantial unmet medical need in moderate-to-severe 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 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/20191017005896/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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