- All three doses of lebrikizumab met primary endpoint with
statistical significance- Lebrikizumab was well-tolerated; safety
profile consistent with prior studies- Efficacy and safety profile
support advancement into Phase 3; planned by end of 2019-
Conference call and webcast today at 8:30 a.m. ET / 5:30 a.m.
PT
Dermira, Inc. (NASDAQ: DERM), a biopharmaceutical company dedicated
to bringing biotech ingenuity to medical dermatology by delivering
differentiated, new therapies to the millions of people living with
chronic skin conditions, today announced positive results from a
Phase 2b dose-ranging study of lebrikizumab, an investigational
therapy, in adult patients with moderate-to-severe atopic
dermatitis. All three doses of lebrikizumab met the primary
endpoint, demonstrating greater improvements in the Eczema Area and
Severity Index (EASI) score compared to placebo. The safety profile
for lebrikizumab observed in the study was consistent with prior
studies evaluating this investigational therapy.
Lebrikizumab is a novel, injectable, humanized monoclonal
antibody designed to bind interleukin-13 (IL-13) with high
affinity, specifically preventing the formation of the
IL-13Rα1/IL-4Rα heterodimer complex, which inhibits downstream
signaling. 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.
“These data are compelling and further demonstrate clinically
that IL-13 is a key mediator in atopic dermatitis,” said Emma
Guttman-Yassky, M.D., Ph.D., The Sol and Clara Kest Professor, Vice
Chair for Research in the Department of Dermatology, Director of
the Center of Excellence in Eczema at Icahn School of Medicine at
Mount Sinai and a leading study investigator. “I have many patients
for whom current therapies do not adequately address their needs.
These data show that lebrikizumab may offer a targeted, effective
and well-tolerated therapeutic approach.”
About Lebrikizumab Phase 2b StudyAcross all of
the doses evaluated, lebrikizumab showed a dose-dependent and
statistically significant improvement in the primary endpoint, the
mean percent change in EASI score from baseline to week
16. The improvement in EASI score was 62.3% for
patients receiving lebrikizumab, 125 milligrams (mg), every four
weeks (p=0.0165), 69.2% for patients receiving lebrikizumab, 250
mg, every four weeks (p=0.0022) and 72.1% for patients receiving
lebrikizumab, 250 mg, every two weeks (p=0.0005) compared to 41.1%
for patients receiving placebo.
Patients treated with lebrikizumab at the 250 mg dose every two
or four weeks achieved statistically significant improvements in
other key efficacy measures compared to placebo after 16 weeks of
treatment, including:
Lebrikizumab 250 mg every four weeks:
- 33.7% of lebrikizumab-treated patients achieved clearing or
near-clearing of skin lesions, as measured by an
investigator's global assessment (IGA) score of 0 or 1, and a
reduction of at least 2 points from baseline, compared to 15.3%
with placebo (p=0.0392).
- 56.1% of lebrikizumab treated patients achieved a reduction of
at least 75% from baseline in EASI score (EASI-75), compared to
24.3% on placebo (p=0.0021).
- 36.1% of lebrikizumab treated patients achieved a reduction of
at least 90% from baseline in EASI score (EASI-90), compared to
11.4% on placebo (p=0.0062).
Lebrikizumab 250 mg every two weeks:
- 44.6% of lebrikizumab-treated patients achieved clearing or
near-clearing of skin lesions, as measured by an IGA score of
0 or 1, and a reduction of at least 2 points from
baseline, compared to 15.3% with placebo (p=0.0023).
- 60.6% of lebrikizumab treated patients achieved a reduction of
at least 75% from baseline in EASI-75, compared to 24.3% on placebo
(p=0.0005).
- 44.0% of lebrikizumab treated patients achieved a reduction of
at least 90% from baseline in EASI-90, compared to 11.4% on placebo
(p=0.0006).
The secondary endpoints for the 125 mg lebrikizumab dosing arm
did not meet statistical significance.
The most common adverse events reported across all three
lebrikizumab dosing arms were upper respiratory tract infection
(7.5% vs. 5.8% for placebo), nasopharyngitis (6.6% vs. 3.8% for
placebo), headache (3.1% vs. 5.8% for placebo) and injection site
pain (3.1% vs. 1.9% for placebo). Rates of conjunctivitis (2.6%
compared to no reports for placebo) and herpes infections (2.2%
compared to no reports for placebo) were low. Overall, adverse
events observed in lebrikizumab-treated patients were primarily
mild to moderate in severity and infrequently led to treatment
discontinuation.
“Based on the clinical profile observed in this study, we
believe lebrikizumab has the potential to be a best-in-disease
therapy for atopic dermatitis,” said Tom Wiggans, chairman and
chief executive officer of Dermira. “We intend to move quickly into
a Phase 3 program following discussions with U.S. regulators. I
want to thank the patients and investigators who participated in
this trial and hope these contributions will support our ability to
offer a new and differentiated treatment option to the millions of
people struggling to effectively manage their atopic
dermatitis.”
Following an end-of-Phase 2 meeting with the U.S. Food and Drug
Administration, Dermira plans to initiate a Phase 3 clinical
development program for lebrikizumab by the end of 2019.
About the Lebrikizumab Phase 2b StudyThe
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 to establish
the dosing regimen for a potential 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. The study evaluated
three different lebrikizumab treatment dosing arms compared to a
placebo arm, with patients randomized in a 3:3:3:2
fashion:
- Group 1: A loading dose of 250 mg of lebrikizumab at week 0,
followed by 125 mg of lebrikizumab every four weeks.
- Group 2: A loading dose of 500 mg of lebrikizumab at week 0,
followed by 250 mg of lebrikizumab every four weeks.
- Group 3: A loading dose of 500 mg of lebrikizumab at weeks 0
and 2, followed by 250 mg of lebrikizumab every two
weeks.
- Group 4: Placebo at week 0 and every two weeks thereafter.
The inclusion criteria for patients enrolled in this study
included chronic atopic dermatitis for at least one year, an EASI
score of 16 or greater, an IGA score of 3 or 4 and a body surface
area involving at least 10% at screening and baseline. Following
the end of the 16-week assessment period, patients are followed for
an additional 16 weeks.
About Atopic DermatitisAtopic 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 and also includes redness, cracking, dryness and intense,
persistent itching. The skin 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,
injectable, humanized 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.
Conference Call and Webcast Dermira will
host a webcast and conference call today beginning at 5:30
a.m. Pacific Time / 8:30 a.m. Eastern Time. Analysts and
investors can participate in the conference call by dialing (877)
359-9508 for domestic callers and (224) 357-2393 for international
callers using the conference ID# 7987427. The webcast can be
accessed live on the Investor Relations page of Dermira’s website,
http://investor.dermira.com, and will be available for replay for
30 days following the call.
About DermiraDermira 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 nine and older) with primary axillary hyperhidrosis
(excessive underarm sweating). Please see the QBREXZA prescribing
information. Dermira is also evaluating lebrikizumab for the
treatment of moderate-to-severe atopic dermatitis (a severe form of
eczema) and plans to initiate a Phase 3 clinical development
program by the end of 2019; 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; Dermira’s plans to
expedite initiation of a Phase 3 development program for
lebrikizumab and to initiate the program by the end of 2019;
lebrikizumab’s potential to be a best-in-disease therapy for atopic
dermatitis; Dr. Guttman-Yassky’s belief that lebrikizumab may offer
a targeted, effective and well-tolerated therapeutic approach;
Dermira’s anticipated end-of-Phase 2 meeting with the U.S. Food and
Drug Administration; and Dermira’s ability to offer lebrikizumab as
a new treatment option to the millions of people struggling to
effectively manage their 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, implementation and outcomes 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
obtain necessary additional capital; market acceptance of Dermira’s
potential products; the impact of competitive products and
therapies; 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.Contacts:
Media:Erica JeffersonVice President, Corporate
Communications650-421-7216erica.jefferson@dermira.com
Investors:Ian Clements, Ph.D.Vice President, Investor
Relations650-422-7753investor@dermira.com
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