Dermira Completes Patient Enrollment in Phase 2b Dose-Ranging Study Evaluating Lebrikizumab in Patients with Moderate-to-Seve...
24 October 2018 - 7:01AM
Topline efficacy and safety results
anticipated by early April 2019
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 the completion of patient
enrollment in the Phase 2b dose-ranging study evaluating its
anti-IL13 monoclonal antibody, lebrikizumab, in patients with
moderate-to-severe atopic dermatitis. The company expects to
announce topline efficacy and safety results from the study by
early April 2019.
“For many living with moderate-to-severe atopic dermatitis, the
condition can often be debilitating, with patients finding limited
treatment options that are effective at addressing the underlying
cause of the disease,” said Luis Peña, chief development officer of
Dermira. “Given the role of IL-13 in the development of atopic
dermatitis, we believe that lebrikizumab’s distinctive molecular
profile could deliver a compelling combination of efficacy, safety
and convenience to patients living with moderate-to-severe atopic
dermatitis. We look forward to sharing the results by early April
of next year.”
Lebrikizumab Phase 2b StudyThe randomized,
double-blind, placebo-controlled, parallel-group Phase 2b study is
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 in the United States. The study is evaluating 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 each of
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 primary endpoint of the study is the percent change in the
Eczema Area Severity Index (EASI) from baseline to week 16. Key
secondary endpoints that will be evaluated during the 16-week
treatment period include: the proportion of patients with a 75
percent improvement from baseline in EASI (EASI-75); the proportion
of patients with an Investigator’s Global Assessment (IGA) score of
0 (clear) or 1 (almost clear) and a reduction of 2 or more points
(on a 5-point scale) from baseline; the proportion of patients
achieving EASI-50 and EASI-90; and changes in pruritus (itch) and
sleep loss scores from baseline, both scored using an 11-point
numerical rating scale (NRS). Key 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 greater, and a body surface area involving at least 10 percent
at screening and baseline. Following the end of the 16-week
assessment period, patients will be 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,
humanized monoclonal antibody designed to bind IL-13 with high
affinity, specifically preventing the formation of the
IL-13Rα1/IL-4Rα heterodimer complex and subsequent signaling. IL-13
plays a central role in type 2 inflammation and is an important
pathogenic mediator in atopic dermatitis.
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 and develop leading-edge medical dermatology programs. 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).
Dermira is also evaluating lebrikizumab in a Phase 2b clinical
trial for the treatment of moderate-to-severe atopic dermatitis (a
severe form of eczema) and has early-stage research 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 successful completion of, and
timing expectations for the receipt and announcement of topline
efficacy and safety results from the Phase 2b dose-ranging study;
the belief that lebrikizumab’s distinctive molecular profile could
deliver a compelling combination of efficacy, safety and
convenience to patients living with moderate-to-severe atopic
dermatitis; the desired outcome of the Phase 2b dose-ranging study;
the design and description of the Phase 2b dose-ranging study of
lebrikizumab for moderate-to-severe atopic dermatitis; and a
potential Phase 3 program to evaluate the safety and efficacy of
lebrikizumab for the treatment of 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 the design, implementation and outcomes of Dermira’s
clinical trials; Dermira’s dependence on third-party clinical
research organizations, manufacturers and suppliers; 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; Dermira’s ability to develop and maintain
collaborations and license products and intellectual property; the
impact of competitive products and therapies, including generics
and biosimilars; 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 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.
Contacts:
Media:Erica JeffersonVice President, Corporate
Communications650-421-7216media@dermira.com
Investors:Ian Clements, Ph.D.Vice President, Investor
Relations650-422-7753investor@dermira.com
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