- Phase 3 pivotal trials enrolled a total of 1,503 patients-
Topline efficacy and safety results expected in first quarter of
2018
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 the completion of
patient enrollment in its CLAREOS-1 and CLAREOS-2 Phase 3 clinical
trials. Both trials are designed to evaluate the efficacy and
safety of olumacostat glasaretil (formerly DRM01) in patients ages
nine years and older with facial acne vulgaris. Olumacostat
glasaretil is a novel, small molecule designed to target sebum
production following topical application.
“Despite the number of options currently available to treat
acne, the majority of these treatments have been available for more
than 30 years, and patients of all ages continue to seek new
options to effectively and safely manage this common skin
condition,” said Luis Peña, chief development officer at Dermira.
“We continue to believe that olumacostat glasaretil represents a
potential new treatment option for acne with an exciting new
mechanism of action that is designed to target sebum, and we look
forward to sharing topline results from the Phase 3 clinical
program in the first quarter of next year.”
Dermira expects to announce topline efficacy and safety results
from the CLAREOS-1 and CLAREOS-2 studies in the first quarter of
2018. CLARITUDE, a third trial assessing the long-term safety of
olumacostat glasaretil, will continue for an additional nine
months. Positive results from CLAREOS-1 and CLAREOS-2, the
completion of CLARITUDE and other registration-enabling studies and
activities are required to support a potential New Drug Application
(NDA) submission to the U.S. Food and Drug Administration (FDA) for
olumacostat glasaretil.
About Olumacostat Glasaretil Phase 3 ProgramThe
Phase 3 clinical program consists of two randomized, multi-center,
double-blind, parallel-group, vehicle-controlled trials, CLAREOS-1
and CLAREOS-2, designed to assess the efficacy and safety of
olumacostat glasaretil compared to vehicle to support a potential
NDA submission to the FDA. The program enrolled total of 1,503
patients (CLAREOS-1, n=759 and CLAREOS-2, n=744) ages nine years
and older with moderate-to-severe acne vulgaris at 94 sites in the
United States, Canada and Australia. In each trial, patients were
randomized in a 2:1 fashion to receive either olumacostat
glasaretil at a concentration of 5% or vehicle twice daily for 12
weeks.
Consistent with the design of two earlier Phase 2 trials,
inclusion criteria required a minimum of 20 inflammatory and 20
non-inflammatory facial lesions and an Investigator’s Global
Assessment (IGA) score of three or four on a five-point scale that
ranges from a score of zero, representing clear skin, to a score of
four, representing severe disease. The primary endpoints of both
trials will evaluate the absolute changes from baseline in
inflammatory and non-inflammatory lesion counts and the proportion
of patients achieving at least a two-grade improvement from
baseline to a grade of 0 or 1 on the five-point IGA scale.
Secondary endpoints will evaluate the percentage change from
baseline in inflammatory and non-inflammatory lesion counts on the
face and the proportion of patients achieving at least a two-grade
improvement from baseline on the five-point IGA scale. All efficacy
endpoints will be measured at the end of the 12-week treatment
period. Safety will also be assessed.
The Phase 3 program also includes an open-label study,
CLARITUDE, assessing the long-term safety of olumacostat
glasaretil, in which patients from either of the two Phase 3
studies will be permitted to continue to receive treatment for up
to an additional 36 weeks.
About Olumacostat GlasaretilOlumacostat
glasaretil is a novel, small molecule designed to target sebum
production following topical application. Sebum is an oily
substance made up of lipids produced by glands in the skin called
sebaceous glands, and excessive sebum production is an important
aspect of acne that is not addressed by available topical
therapies. Olumacostat glasaretil is designed to exert its effect
by inhibiting acetyl coenzyme-A carboxylase, an enzyme that plays
an important role in the synthesis of fatty acids, a type of lipid
that represents an essential component of the majority of sebum
lipids.
About Acne According to the American Academy of
Dermatology, acne is the most common skin condition in the United
States, affecting approximately 50 million Americans and 85% of all
teenagers. Acne is caused by the accumulation of dead skin cells,
oil and bacteria in pores. It is characterized by clogging of the
pores and associated local skin lesions. Acne lesions are believed
to result from an interaction of multiple pathogenic, or
contributing, factors, including excessive sebum production. Acne
is not just about blemishes on the skin; it can also affect a
person’s quality of life, resulting in social, psychological and
emotional impairments.
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.
Dermira’s pipeline includes four late-stage product candidates that
could have a profound impact on the lives of patients: CIMZIA®
(certolizumab pegol), for which marketing applications have been
submitted for potential approval for the treatment of
moderate-to-severe chronic plaque psoriasis, in collaboration with
UCB Pharma S.A.; glycopyrronium tosylate (formerly DRM04), for
which a Phase 3 program has been completed for the treatment of
primary axillary hyperhidrosis (excessive underarm sweating);
olumacostat glasaretil (formerly DRM01), in Phase 3 development for
the treatment of acne vulgaris; and lebrikizumab, for which Dermira
plans to initiate a Phase 2b dose-ranging study for the treatment
of moderate-to-severe atopic dermatitis. Dermira is
headquartered in Menlo Park, Calif. For more information,
please visit http://www.dermira.com.
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) and LinkedIn
page (https://www.linkedin.com/company/dermira-inc) 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 and LinkedIn page in addition to following its SEC filings,
press 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; olumacostat glasaretil representing a
potential new treatment option for acne; the design of the
olumacostat glasaretil Phase 3 clinical program; the successful
completion of, and timing expectations for the receipt of data
from, the olumacostat glasaretil Phase 3 program; a potential NDA
submission to the FDA for olumacostat glasaretil; and Dermira’s
plan to initiate a Phase 2b dose-ranging study of lebrikizumab for
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; 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
Robert H. Uhl Westwicke PartnersManaging
Director858-356-5932robert.uhl@westwicke.com
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