Dermira, Inc. (NASDAQ:DERM), a biopharmaceutical company dedicated
to identifying, developing and commercializing innovative,
differentiated therapies to improve the lives of patients with
dermatologic diseases, presented data from its DRM01 Phase 2b
clinical trial at the 35th Anniversary Fall Clinical Dermatology
Conference in Las Vegas.
Positive topline results from the DRM01 Phase 2b dose-ranging
clinical trial were previously reported in May 2016. The trial
evaluated the safety and efficacy of DRM01, a novel, small molecule
designed to inhibit sebum production following topical application.
The primary endpoints for the trial were absolute changes from
baseline in inflammatory and non-inflammatory lesion counts and the
proportion of patients achieving at least a two-point improvement
from baseline on the five-point Investigator’s Global Assessment
(IGA) scale. Each endpoint was assessed by comparison of baseline
values with those measured at the end of a 12-week treatment
period.
“Acne is one of the most common skin conditions affecting
millions of people of all ages,” said Jim Del Rosso, D.O., an
adjunct clinical professor of dermatology at Touro University
College of Osteopathic Medicine.* “Although the marketplace is full
of prescription and over-the-counter treatment options for
patients, very few target one of the underlying causes of acne in
both a safe and effective manner for patients.”
As previously reported, DRM01 demonstrated statistically
significant improvements from baseline to week 12 relative to
vehicle in all primary efficacy endpoints at the highest dose of
DRM01 tested and in most primary endpoints at the two lower doses
tested. DRM01 was well-tolerated across all three doses, with
adverse events primarily mild or moderate in severity.
DRM01 Dose: 7.5% twice daily
At the 7.5% twice daily dose, DRM01 demonstrated statistically
significant improvements from baseline to week 12 relative to
vehicle in all primary efficacy endpoints. This highest dose of
DRM01 also demonstrated the highest efficacy in all primary
endpoints compared to the two lower doses.
- Following 12 weeks of treatment, the number of inflammatory
lesions in patients treated with this highest dose of DRM01 was
reduced by an average of 15.0 compared to 10.7 in patients in the
combined vehicle group (p=0.001), or an average percentage
reduction of 55.6% compared to 40.0% (p<0.001). The number of
non-inflammatory lesions in patients treated with this same dose of
DRM01 was reduced by an average of 17.5 compared to 9.3 in patients
in the combined vehicle group (p<0.001), or an average
percentage reduction of 47.8% compared to 28.7% (p<0.001).
- At the end of the same 12-week treatment period, 25.9% of
patients achieved a successful improvement in the IGA score
(minimum two-grade improvement) compared to 9.8% of patients in the
combined vehicle group (p=0.004).
DRM01 Dose: 7.5% once daily
At the 7.5% once daily dose, DRM01 demonstrated statistically
significant improvements in the inflammatory and non-inflammatory
lesion count endpoints compared to the combined vehicle group, and
approached but did not reach statistical significance in the IGA
improvement endpoint.
- Following 12 weeks of treatment, the number of inflammatory
lesions in patients treated with this dose of DRM01 was reduced by
an average of 14.5 compared to 10.7 in patients in the combined
vehicle group (p=0.004), or an average percentage reduction of
53.3% compared to 40.0% (p=0.004). The number of non-inflammatory
lesions in patients treated with DRM01 at the 7.5% dose once daily
was reduced by an average of 13.4 compared to 9.3 in patients in
the combined vehicle group (p=0.050), or an average percentage
reduction of 36.6% compared to 28.7% (p=0.152).
- At the end of the same 12-week treatment period, 19.2% of
patients achieved a successful improvement in the IGA score
(minimum two-grade improvement) compared to 9.8% of patients in the
combined vehicle group (p=0.063).
DRM01 Dose: 4.0% once daily
At the 4.0% once daily dose, DRM01 demonstrated statistically
significant improvements in all three primary endpoints compared to
the combined vehicle group.
- Following 12 weeks of treatment, the number of inflammatory
lesions in patients treated with this dose of DRM01 was reduced by
an average of 14.6 compared to 10.7 in patients in the combined
vehicle group (p=0.003), or an average percentage reduction of
54.8% compared to 40.0% (p=0.002). The number of non-inflammatory
lesions in patients treated with DRM01 at the 4.0% dose once daily
was reduced by an average of 15.3 compared to 9.3 in patients in
the combined vehicle group (p=0.004), or an average percentage
reduction of 42.1% compared to 28.7% (p=0.014).
- At the end of the same 12-week treatment period, 21.6% of
patients achieved a successful improvement in the IGA score
(minimum two-grade improvement) compared to 9.8% of patients in the
combined vehicle group (p=0.024).
“We are excited to share additional results from the Phase 2b
clinical program with the dermatology community, which demonstrate
that DRM01 could potentially be a safe and effective treatment
option for patients suffering from acne,” said Eugene A. Bauer,
M.D., chief medical officer of Dermira. “We look forward to
initiating our Phase 3 clinical program for DRM01.”
DRM01 was well-tolerated in the Phase 2b trial. Adverse events
were primarily mild or moderate in severity. The most frequently
reported adverse events across all three DRM01 treatment groups
were common cold (nasopharyngitis; 5.4%), upper respiratory tract
infection (2.5%) and application site itching (pruritus; 2.5%). No
treatment-related serious adverse events were reported.
Based on the results of the Phase 2b trial and an end-of-Phase 2
meeting with the U.S. Food and Drug Administration (FDA), Dermira
plans to initiate a Phase 3 program to evaluate the safety and
efficacy of DRM01 as a potential treatment for acne in adult and
adolescent patients. The initiation of this program is targeted for
the first half of 2017, consistent with previous guidance.
About DRM01 Phase 2b Trial
The DRM01 Phase 2b trial was a randomized, multi-center,
double-blind, parallel-group, vehicle-controlled study designed to
assess the safety and efficacy of DRM01 compared to vehicle in
adult patients 18 and older with moderate-to-severe facial acne
vulgaris. A total of 420 patients were enrolled in the study at 34
sites in the United States and Canada. Inclusion criteria required
a minimum of 20 inflammatory lesions and 20 non-inflammatory
lesions and an IGA score of three or greater on a five-point scale
that ranges from a score of zero, representing clear skin, to a
score of four, representing severe disease. Patients were
randomized into five separate arms and instructed to apply DRM01 at
concentrations of 4.0% once daily (n=106), 7.5% once daily (n=110)
or 7.5% twice daily (n=101), or to apply vehicle once or twice
daily (n=53 and n=50, respectively), in all cases for 12 weeks.
Consistent with the previous Phase 2a trial and in accordance with
the published FDA draft guidance for the development of acne drugs,
the primary endpoints were absolute changes from baseline in
inflammatory and non-inflammatory lesion counts and the proportion
of patients achieving at least a two-point improvement from
baseline in the five-point IGA score. Each endpoint was measured at
the end of the 12-week treatment period.
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. 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 DRM01
DRM01 is a novel, small molecule designed to inhibit sebum
production following topical application in development for the
treatment of acne. 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. DRM01 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 Dermira
Dermira is a biopharmaceutical company dedicated to identifying,
developing and commercializing innovative, differentiated therapies
to improve the lives of patients with dermatologic diseases.
Dermira’s portfolio includes three late-stage product candidates
that target significant unmet needs and market opportunities:
CIMZIA® (certolizumab pegol), in Phase 3 development in
collaboration with UCB Pharma S.A. for the treatment of
moderate-to-severe chronic plaque psoriasis; DRM04, in Phase 3
development for the treatment of primary axillary hyperhidrosis
(excessive underarm sweating); and DRM01, in Phase 2b development
for the treatment of facial acne vulgaris. Dermira is headquartered
in Menlo Park, California. For more information, please visit
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 StatementsThe 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 the potential use of DRM01 as
a safe and effective treatment option for patients with acne and
the timing, initiation, dose and design of a Phase 3 program for
DRM01. 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 outcome of Dermira’s
planned DRM01 Phase 3 program; the outcome of Dermira’s future
discussions with regulatory authorities relating to the DRM01
clinical program; Dermira’s ability to obtain regulatory approval
for DRM01; Dermira’s dependence on third-party clinical research
organizations, manufacturers and suppliers; and Dermira’s ability
to continue to stay in compliance with applicable laws and
regulations. For a discussion of important factors that may cause
Dermira’s actual results to differ materially from those expressed
or implied by Dermira’s forward-looking statements, you should
refer to the section entitled “Risk Factors” set forth in Dermira’s
Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and
other filings Dermira makes with the SEC from time to time.
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.
*Disclaimer: Dr. Del Rosso serves as a paid advisor to Dermira.
He does not have a financial interest in the company.
Contacts:
Media:
Erica Jefferson
Senior Director, Head of Corporate Communications
650-421-7216
erica.jefferson@dermira.com
Investors:
Andrew Guggenhime
Chief Operating Officer and Chief Financial Officer
650-421-7200
investors@dermira.com
Robert H. Uhl
Westwicke Partners
Managing Director
858-356-5932
robert.uhl@westwicke.com
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