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 Phase 2b study with sofpironium bromide in patients with
primary axillary hyperhidrosis were published in the peer-reviewed
Journal of the American Academy of Dermatology (JAAD).
The paper, entitled “Efficacy and Safety of
Topical Sofpironium Bromide Gel for the Treatment of Axillary
Hyperhidrosis: A Phase 2, Randomized, Controlled, Double-Blinded
Trial,” is now available online (Journal Pre-proof) at
(https://doi.org/10.1016/j.jaad.2020.02.016) and will be published
in a future print edition of JAAD.
Sofpironium bromide is an innovative,
retro-metabolically designed, anticholinergic new molecular entity
under investigation for the topical treatment of primary axillary
hyperhidrosis. In this Phase 2b dose-finding study, sofpironium
bromide elicited clinically and statistically significant sustained
reductions in sweating severity and was well tolerated, suggesting
that pivotal Phase 3 studies in the U.S. of this investigational
drug are warranted. Brickell and its Japanese partner, Kaken
Pharmaceutical Co., Ltd. (“Kaken”) have conducted a range of
clinical studies with sofpironium bromide in over 1,300 subjects,
including a Phase 3 registration trial in Japan.
“We are encouraged by these Phase 2b study
results and are pleased by the publication of these data in such a
prestigious academic peer-reviewed journal,” said Deepak Chadha,
M.S. M.B.A., Brickell’s Chief Research & Development Officer.
“These study results give us the confidence to continue to
advance the development of sofpironium bromide.”
Stacy Smith, MD, an author, study investigator,
and head of the California Dermatology and Clinical Research
Institute, said, “The publication of these results are important to
the millions of hyperhidrosis sufferers in the U.S. The dermatology
community needs new treatment options to effectively
manage hyperhidrosis patients and give them the quality of
life they seek.”
Key findings from this study include:
- Topically applied sofpironium
bromide gel, at concentrations of 5%, 10% and 15%, showed
statistically significant differences relative to vehicle in
axillary hyperhidrosis severity as demonstrated by improvement in
Hyperhidrosis Disease Severity Measure–Axillary (HDSM-Ax; a
proprietary validated patient report outcome measure),
Hyperhidrosis Disease Severity Scale (HDSS), and modified
Dermatology Life Quality Index-Axilla (DLQI-Ax). The HDSM-Ax and
HDSS assessments showed improvements as early as the first
post-baseline visit on day 8 and were sustained during the
treatment period. The DLQI-Ax was assessed at the baseline
and end of treatment only.
- Although the Phase 2b study was not
designed to detect treatment differences in Gravimetric Sweat
Production (GSP), an objective measure of reduction in sweat
production. sofpironium bromide gel, 15%, demonstrated a
statistically significant result over vehicle.
- Across all dose groups, adverse
events were predominantly mild or moderate in severity and
transient in nature. Safety and tolerability assessments exhibited
dose-related trends. The most common adverse events with
sofpironium bromide were dry mouth and blurred vision, which are
expected anticholinergic side effects.
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 considerably 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, are believed to suffer from
hyperhidrosis. 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. Doolittle et al. Arch Dermatol Res (2016).
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, cutaneous T-cell
lymphoma, psoriasis, 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®. 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 are forward-looking statements within the meaning of the
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 prescription
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
Brickell Biotech (NASDAQ:BBI)
Historical Stock Chart
From Jul 2024 to Jul 2024
Brickell Biotech (NASDAQ:BBI)
Historical Stock Chart
From Jul 2023 to Jul 2024