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 presented new findings from its
glycopyrronium tosylate (formerly DRM04) Phase 3 clinical program.
The data showed that when applied topically, the investigational
therapy improved disease severity, reduced sweat production and was
associated with improved quality of life outcomes for pediatric
patients (ages 9 to 16) with primary axillary hyperhidrosis
(excessive underarm sweating), compared to vehicle-treated
patients.
These findings are consistent with results previously reported
in adult patients (ages 17 and older). The data were featured in an
oral presentation during the Late-Breaking Research Forums at the
76th Annual Meeting of the American Academy of Dermatology (AAD) in
San Diego.
Primary axillary hyperhidrosis is a medical condition that
results in sweating beyond what is needed for normal body
temperature regulation. Glycopyrronium tosylate is an
investigational agent formulated as a topical, once-daily
anticholinergic wipe, designed to block sweat production by
inhibiting the interaction between acetylcholine and the
cholinergic receptors responsible for sweat gland activation.
“Primary axillary hyperhidrosis has long been associated with
social stigma, isolation and embarrassment,” said Adelaide Hebert,
M.D., Chief of Pediatric Dermatology at McGovern Medical School at
UTHealth, Houston and Children’s Memorial Hermann Hospital, and a
lead investigator for the Phase 3 clinical program. “We know that
young people with axillary hyperhidrosis are experiencing these
effects at a critical time in their physical and social
development. If left unaddressed, these effects could lead to
profound emotional and social distress that has a negative impact
on overall quality of life.1”
Phase 3 ATMOS-1 and ATMOS-2 Pediatric Post-Hoc
Analysis
- ATMOS-1 and ATMOS-2 were designed as multi-center, randomized,
double-blind, vehicle-controlled, four-week Phase 3 trials
assessing the efficacy and safety of glycopyrronium tosylate in
patients ages 9 years of age and older. Patients had primary
axillary hyperhidrosis for six months or more, produced at least 50
mg of sweat in each underarm over a five-minute period and rated
the severity of their sweating as a four or higher on an 11-point
numerical rating scale (Axillary Sweating Daily Diary
(ASDD)/Children’s ASDD [ASDD-C]; Item 2), and had a three or a four
on the four-grade Hyperhidrosis Disease Severity Scale (HDSS). All
patients were evaluated after four weeks of treatment with
glycopyrronium tosylate or vehicle.
- Overall, 463 patients were randomized to glycopyrronium
tosylate and 234 to vehicle. Of these, 44 were pediatric patients,
ages 9 to 16 years of age (glycopyrronium tosylate, n=25; vehicle,
n=19). Baseline disease characteristics were similar between age
groups.
- Efficacy results were consistent among pediatric and adult
patients. Specifically, pooled ASDD/ASDD-C severity scale responder
rates for pediatric vs. adult patients were 59.9% vs. 60.2% for
glycopyrronium tosylate-treated and 13.0% vs. 28.8% for
vehicle-treated patients, respectively.
- The median absolute changes in sweat production at week four
for pediatric vs. adult patients were -64.2 mg vs. -80.6 mg for
glycopyrronium tosylate-treated and -53.7 mg vs. -62.0 mg for
vehicle-treated patients, respectively.
- The proportions of patients experiencing a reduction of at
least 50 percent in sweat production at week four for pediatric vs.
adult patients were 79.9% vs. 74.3% of glycopyrronium
tosylate-treated and 54.8% vs. 53.0% of vehicle-treated patients,
respectively.
- The mean decrease from baseline in the Children’s Dermatology
Quality of Life Index was -8.1 for glycopyrronium tosylate-treated
vs. -1.9 for vehicle-treated patients. This is consistent with that
observed for the Dermatology Life Quality Index measure observed
for adults, -8.4 for glycopyrronium tosylate-treated vs. -4.7 for
vehicle-treated patients.
- The rates of treatment emergent adverse events* reported for
pediatric vs. adult patients were 44.0% vs. 56.7% of glycopyrronium
tosylate-treated and 10.5% vs. 34.3% of vehicle-treated patients,
respectively. Most were related to anticholinergic activity and
were mild, transient and infrequently led to drug
discontinuation.
“We are encouraged by the new pediatric data analyses from the
Phase 3 clinical trials which reported the safety and efficacy of
glycopyrronium tosylate in patients as young as nine years old,”
said Eugene A. Bauer, M.D., chief medical officer of Dermira and a
dermatologist. “Importantly, glycopyrronium tosylate also
demonstrated its potential to reduce the daily burden of the
condition for individuals at a critical stage in their emotional
and social development. These results add to growing body of
evidence which suggests that glycopyrronium tosylate could one day
be an important new treatment option for millions of axillary
hyperhidrosis suffers seeking treatments to more effectively manage
this condition.”
About HyperhidrosisHyperhidrosis 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 million people.2 Of these, 65
percent, or nearly 10 million people, suffer from sweating
localized to the underarms (axillary hyperhidrosis). Studies have
further demonstrated that excessive sweating often impedes normal
daily activities and can also result in occupational, emotional,
social and physical impairment.3,4 New research indicates that one
third of survey respondents indicated their primary axillary
hyperhidrosis began before the age of 12, suggesting that axillary
hyperhidrosis may affect patients younger than previously
identified.5
About Glycopyrronium Tosylate and the Phase 3
StudiesGlycopyrronium tosylate is an investigational agent
formulated as a topical, once-daily anticholinergic wipe, designed
to block sweat production by inhibiting the interaction between
acetylcholine and the cholinergic receptors responsible for sweat
gland activation.
In November 2017, the U.S. Food and Drug Administration (FDA)
accepted a new drug application (NDA) for glycopyrronium tosylate
based on results from ATMOS-1 and ATMOS-2, Phase 3 clinical trials
designed to assess the safety and efficacy of glycopyrronium
tosylate compared to vehicle in adolescent and adult patients (ages
nine and older) with primary axillary hyperhidrosis. In addition to
these two trials, an open-label trial, ARIDO, assessed the
long-term safety of glycopyrronium tosylate. The Prescription Drug
User Fee Act target date for the completion of the FDA’s review of
the NDA is June 30, 2018.
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 three late-stage product candidates that could have a
profound impact on the lives of patients: glycopyrronium tosylate
(formerly DRM04), for which a New Drug Application is under review
by the U.S. Food and Drug Administration for the treatment of
primary axillary hyperhidrosis (underarm sweating beyond what is
needed for normal body temperature regulation); olumacostat
glasaretil (formerly DRM01), in Phase 3 development for the
treatment of acne vulgaris; and lebrikizumab, in Phase 2b
development 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 Dermira 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.
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 an important new treatment option for millions of axillary
hyperhidrosis suffers seeking treatments to more effectively manage
the condition; and the target date for completion of the FDA’s
review of the NDA for glycopyrronium tosylate. 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.
References
- Bohaty et. Al., Special Considerations for Children with
Hyperhidrosis. Dermatologic Clinics 32 (4): 477-484, 2014.
- Doolittle et. al., Hyperhidrosis: An Update on Prevalence and
Severity in the United States. Arch Dermatol Res. 308:743-749,
2016.
- 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.
- Augustin et. al., Prevalence and disease burden of
hyperhidrosis in the adult population. Dermatology. 227: 10-13,
2013.
- Glaser et. al., Prevalence of Multifocal Primary Hyperhidrosis
and Symptom Severity Over Time: Results of a Targeted Survey.
Dermatologic Surgery. 42(12), 1347–1353, 2016.
Dermira 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
Robert H. UhlWestwicke PartnersManaging
Director858-356-5932Robert.uhl@westwicke.com
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