- Daily treatment with glycopyrronium tosylate in
the Phase 3, open-label ARIDO trial was generally well-tolerated
during 44 weeks of treatment- Efficacy assessment suggests sweat
reduction levels were maintained in patients treated with
glycopyrronium tosylate during the extended study
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 highlighted results from ARIDO,
a Phase 3 open-label extension study. ARIDO assessed the long-term
safety of topical, once-daily treatment with glycopyrronium
tosylate in patients with primary axillary hyperhidrosis (excessive
underarm sweating), a medical condition that results in sweating
beyond what is needed for normal body temperature regulation.
After an additional 44 weeks of treatment, glycopyrronium
tosylate was generally well-tolerated by most patients with a low
rate of discontinuation attributed to treatment-emergent adverse
events (TEAEs)*. These findings were consistent with those observed
in previous trials. An efficacy assessment also suggests that
patients treated with glycopyrronium tosylate in ARIDO experienced
a sustained response to the investigational therapy during the
44-week treatment period. The newly reported findings were
presented at the 36th Annual Fall Clinical Dermatology Conference
taking place in Las Vegas, October 12-15.
Glycopyrronium tosylate is an anticholinergic agent, formulated
for once-daily application using a topical wipe. Glycopyrronium
tosylate is designed to block sweat production by inhibiting the
receptors responsible for sweat gland activation.
“The findings from the ARIDO study are important in that they
further demonstrate that glycopyrronium tosylate is generally
well-tolerated, with a side-effect profile that is consistent with
earlier studies,” said Eugene A. Bauer, M.D., chief medical officer
of Dermira and a dermatologist. “We are also encouraged that the
efficacy assessment conducted at the end of ARIDO suggests that
patients continued to respond to topical treatment with
glycopyrronium tosylate during the treatment extension period.
People suffering from hyperhidrosis are in need of new treatment
alternatives and it is our hope that glycopyrronium tosylate might
one day be an option for people living with this condition, which
has been shown to have a profound effect on quality of
life.”
ARIDO was designed to assess the long-term safety of
glycopyrronium tosylate in adolescent and adult patients (ages nine
and older) who participated in ATMOS-1 and ATMOS-2, two identical,
Phase 3 clinical trials, which evaluated the safety and efficacy of
the investigational therapy compared to vehicle for primary
axillary hyperhidrosis over a four-week treatment period. Results
from the ATMOS-1 and ATMOS-2 trials were reported in June 2016.
Patients from the ATMOS-1 and ATMOS-2 trials were permitted to
enroll in ARIDO to receive up to an additional 44 weeks of
treatment with glycopyrronium tosylate. The majority of patients
who completed the trials, or approximately 86.6% of patients
(n=564), opted to receive treatment with glycopyrronium tosylate as
part of the ARIDO study. Of the patients enrolled in ARIDO, 16.3%
(n=92) were lost to follow-up, 14.5% (n=82) withdrew their consent,
7.8% (n=44) discontinued due to an adverse event and 2.5% (n=14)
discontinued for other reasons. Additionally, 18.8% (n=106) were
discontinued on treatment as Dermira terminated the study early,
having met its objective of enrolling at least 100 patients who
received treatment with glycopyrronium tosylate for at least 12
months. As a result, at the conclusion of the 44-week treatment
period, 40.1% of patients (n=226) completed ARIDO.
Phase 3 ARIDO Study Outcomes
- After an additional 44 weeks of treatment, 59.8% of patients
(n=329) reported one or more TEAE, and most were considered mild or
moderate in severity. The most frequently reported TEAEs observed
in patients were dry mouth (16.9%; n=93), blurred vision (6.7%;
n=37), application site pain (6.4%; n=35), the common cold (5.8%;
n=32) and pupil dilation (5.3%; n=29). Prespecified anticholinergic
TEAEs of interest, defined as those associated with a subset of
anticholinergic side effects, were reported in 14.2% of patients
(n=78) and most were mild or moderate in severity and were able to
be managed by dose interruption. Serious TEAEs were reported in
1.3% of patients (n=7). The incidence of TEAEs, including
prespecified anticholinergic TEAEs of interest, did not increase
over time with longer duration of glycopyrronium treatment.
- An efficacy assessment conducted at the end of the treatment
period in ARIDO suggests that patients who received glycopyrronium
tosylate and completed the 44-week follow-up period maintained
reduced sweat production compared to baseline and reported less
bothersome sweating compared to baseline measures in ATMOS-1 and
ATMOS-2. Notably, mean sweat production decreased by 95.77 ±140.8
mg/5 min and 63.2% of patients had ≥2-grade improvement in the
Hyperhidrosis Disease Severity Scale (HDSS).
About Hyperhidrosis Hyperhidrosis is a
condition of sweating beyond what is physiologically required for
normal thermal regulation and affects an estimated 4.8% of the U.S.
population, or approximately 15.3 million people.1 Of these, 65
percent, or nearly 10 million people, suffer from sweating
localized to the underarms (axillary disease). Studies have further
demonstrated that excessive sweating often impedes normal daily
activities and can also result in occupational, emotional,
psychological, social and physical impairment.2,3
About Glycopyrronium TosylateGlycopyrronium
tosylate is a once-daily anticholinergic agent, administered as a
topical wipe, for which Dermira has completed a Phase 3 program for
the treatment of primary axillary hyperhidrosis. Glycopyrronium
tosylate is designed to block sweat production by inhibiting the
interaction between acetylcholine and the cholinergic receptors
responsible for sweat gland activation.
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. Follow
@DermiraInc on Twitter and LinkedIn.
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) 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 and Twitter account in addition to following its SEC filings,
press releases, public conference calls and webcasts.
Dermira 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; glycopyrronium
tosylate potentially becoming a treatment option for people living
with hyperhidrosis; 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; the outcome of future discussions with regulatory
authorities; 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. 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.
*Treatment emergent adverse events are defined as any safety
related side effect not present prior to the start of a treatment
or any event that already exists in a person that worsens in either
intensity or frequency following exposure to the treatment.
References1. Doolittle et. al., Hyperhidrosis:
An Update on Prevalence and Severity in the United States. Arch
Dermatol Res. 308:743-749, 2016.
2. Bahar et. al., The prevalence of anxiety and depression in
patients with or without hyperhidrosis (HH). J Am Acad Dermatol.
75(6): 1126-1133, 2016.
3. Augustin et. al., Prevalence and disease burden of
hyperhidrosis in the adult population. Dermatology. 227: 10-13,
2013.
Contacts:
Media:Erica Jefferson Vice President, Corporate Communications
650-421-7216 media@dermira.com
Investors:Ian Clements, Ph.D.Vice President, Investor Relations
650-422-7753investors@dermira.com
Robert H. Uhl Westwicke Partners Managing Director 858-356-5932
robert.uhl@westwicke.com
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