Brickell Biotech Announces Late-Breaking Oral Presentation at 2020 American Academy of Dermatology Annual Meeting by its Asia...
04 Marzo 2020 - 5:30AM
Brickell Biotech, Inc. (“Brickell”) (Nasdaq: BBI), a clinical-stage
pharmaceutical company focused on developing innovative and
differentiated prescription therapeutics for the treatment of
debilitating skin diseases, today announced that positive results
from its development partner, Kaken Pharmaceutical Co. Ltd.’s Phase
3 pivotal study in Japan were selected for oral presentation at the
Late-Breaking Research Program during the American Academy of
Dermatology (AAD) Annual Meeting being held March 20-24, 2020, in
Denver, CO.
The presentation, which will include the
efficacy and safety results from the Phase 3 pivotal study of
sofpironium bromide being announced for the first time, will be
given as follows:
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Oral Presentation Title: |
A Phase 3, Randomized, Double-Blinded, Vehicle-Controlled Study to
Evaluate the Safety and Efficacy of Topically Applied Sofpironium
Bromide Gel, 5% in Japanese Patients with Primary Axillary
Hyperhidrosis |
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Date and Time: |
Saturday, March 21, 2020, 11:40 AM – 11:50 AM Mountain Time |
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Session: |
S027 - Late-Breaking Research: Clinical Trials |
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Room: |
Bellco Theatre 2 |
About Sofpironium Bromide
Sofpironium bromide, is a proprietary new
molecular entity that belongs to a class of medications called
anticholinergics. Anticholinergics block the action of
acetylcholine, a chemical that transmits signals within the nervous
system that are responsible for a range of bodily functions,
including activation of the sweat glands. Sofpironium bromide was
retrometabolically designed. Retrometabolic drugs are designed to
exert their action topically and are potentially rapidly
metabolized into a less active metabolite once absorbed into the
blood. This proposed mechanism of action may allow for highly
effective doses to be used while limiting systemic side effects.
Sofpironium bromide was discovered at Bodor Laboratories, Inc. by
Dr. Nicholas Bodor D.Sc., d.h.c. (multi), HoF, Graduate Research
Professor Emeritus, University of Florida.
About Hyperhidrosis
Hyperhidrosis is a life-altering medical
condition where a person sweats more than the body requires to
regulate its temperature. More than 15 million people, or 4.8% of
the population of the United States and more than 16 million
people, or 12.76% of the population in Japan, are believed to
suffer from hyperhidrosis1,2. Axillary (underarm) hyperhidrosis is
the targeted first indication for sofpironium bromide and is the
most common site of occurrence of hyperhidrosis, affecting an
estimated 65% of patients with hyperhidrosis in the United States
or 10 million individuals and an estimated 45% of patients with
hyperhidrosis in Japan or 7.2 million individuals1,2.
The FDA selected hyperhidrosis as one of eight
new disease areas that it focused on under its Patient-Focused Drug
Development Initiative (PFDDI) in 2016-2017. The goal of the PFDDI
was to bring patient perspectives into an earlier stage of product
development. Following the FDA’s PFDDI meeting held
in November 2017 on hyperhidrosis, the International
Hyperhidrosis Society summarized the input shared by patients and
patient representatives in a Voice of the Patient report.
Additional information on the PFDDI, including a recording of the
meeting, is available online.
____________1 Doolittle et al. Hyperhidrosis: an
update on prevalence and severity in the United States. Arch
Dermatol Res 2016; 308: 743-749.2 Fujimoto et al. Epidemiological
study and considerations of focal hyperhidrosis in Japan. J
Dermatol 2013; 40: 886-90.
About Brickell
Brickell Biotech, Inc. is a clinical-stage
pharmaceutical company focused on developing innovative and
differentiated prescription therapeutics for the treatment of
debilitating skin diseases. Brickell’s pipeline consists of
potential novel therapeutics for hyperhidrosis and other prevalent
dermatological conditions. Brickell’s executive management team and
board of directors bring extensive experience in product
development and global commercialization, having served in
leadership roles at large global pharmaceutical companies and
biotechs that have developed and/or launched successful products,
including several that were first-in-class and/or achieved iconic
status, such as Cialis®, Taltz®, Gemzar®, Prozac®, Cymbalta® and
Juvederm®. Brickell’s strategy is to leverage this experience to
in-license, acquire, develop and commercialize innovative products
that Brickell believes can be successful in the currently
underserved dermatology global marketplace. For more information,
visit www.brickellbio.com.
Cautionary Note Regarding
Forward-Looking Statements
Any statements made in this press release
relating to future financial, business and/or research and clinical
performance, conditions, plans, prospects, trends, or strategies
and other such matters, including without limitation, the
anticipated timing, scope, design and/or results of future clinical
trials and prospects for commercializing any of Brickell’s product
candidates, including in Japan, the U.S. or any other country, are
forward-looking statements within the meaning of the U.S. Private
Securities Litigation Reform Act of 1995. In addition, when or if
used in this press release, the words “may,” “could,” “should,”
“anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,”
“predict” and similar expressions and their variants, as they
relate to Brickell, may identify forward-looking statements.
Brickell cautions that these forward-looking statements are subject
to numerous assumptions, risks, and uncertainties, which change
over time, often quickly and in unanticipated ways. Important
factors that may cause actual results to differ materially from the
results discussed in the forward-looking statements or historical
experience include risks and uncertainties, including without
limitation, ability to obtain adequate financing to advance product
development, potential delays for any reason in product
development, regulatory or law changes, unanticipated demands on
cash resources, risks associated with developing, and obtaining
regulatory approval for and commercializing novel therapeutics.
Further information on the factors and risks
that could cause actual results to differ from any forward-looking
statements are contained in Brickell’s filings with the United
States Securities and Exchange Commission (SEC), which are
available at www.sec.gov (or at www.brickellbio.com). The
forward-looking statements represent the estimates of Brickell as
of the date hereof only, and Brickell specifically disclaims any
duty or obligation to update forward-looking statements.
Brickell Investor Contact:Patti
BankManaging Director, WestwickeIR@brickellbio.com
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