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 the release of positive
Phase 3 pivotal study results from its development partner, Kaken
Pharmaceutical Co. Ltd., in Japan. All primary and secondary
efficacy endpoints of the study were met. The results were
presented as part of the Late-Breaking Research Program during the
American Academy of Dermatology (AAD) Virtual Meeting Experience.
The presentation is titled “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.” Earlier this year,
Kaken announced submission of a new drug application for approval
in Japan of manufacturing and marketing of sofpironium bromide gel
for primary axillary hyperhidrosis based on these data.
“We are encouraged by these positive results and
are pleased by the filing of the Japanese New Drug Application
based on this Phase 3 study by Kaken,” said Deepak Chadha,
Brickell’s Chief Research & Development Officer. “We believe
there is growing interest from the global medical community for
novel therapeutic options for the treatment of primary axillary
hyperhidrosis and think these data provide additional clinical
support for sofpironium bromide to be a potential best-in-class
treatment.”
The Phase 3 pivotal study evaluated a total of
281 Japanese subjects randomized 1:1 to apply sofpironium bromide
gel, 5% (“SB”) or vehicle gel (placebo) to the axillae for 42 days.
All subjects had Hyperhidrosis Disease Severity Scale (HDSS) scores
≥ 3 and ≥ 50 mg/5 min gravimetric sweat production (GSP) in each
axilla at baseline.
All primary and secondary efficacy endpoints
demonstrated statistically significant differences between
sofpironium bromide and vehicle, with safety and tolerability, as
follows:
Primary Endpoint:
- Proportion of subjects whose HDSS was improved to a score of 1
or 2 at the end of treatment (EOT) and > 50% reduction in GSP at
EOT was 53.9% (SB) versus 36.4% (vehicle); p-value = 0.003
Key Secondary Endpoints:
- Proportion of subjects whose HDSS was improved to a score of 1
or 2 at the EOT was 60.3% (SB) versus 47.9% (vehicle);
p=0.036
- Change in the total GSP mean value for both axillae from
baseline to EOT was -157.6 mg (SB) versus
-127.6 mg (vehicle);
p=0.0151
- Change in the HDSM-Ax score from baseline to EOT was -1.41 (SB)
versus -0.93 (vehicle); p=0.001
- Proportion of subjects with ≥50% reduction in the rate of GSP
from baseline to EOT was 77.3% (SB) versus 66.4% (vehicle);
p=0.042
Safety and Tolerability:
- Common adverse events (incidence ≥5%) in SB group were
nasopharyngitis (14.2%), dermatitis at the application site (8.5%),
and erythema at the application site (5.7%). The severity of
adverse events was predominantly mild.
- 2.8% of SB-treated subjects experienced any
anticholinergic-class side effects; dry mouth (1.4%), constipation
(0.7%) and mydriasis (0.7%).
- No serious adverse events related to SB were reported in the
study
In addition to Japan, Kaken has rights to
develop and commercialize sofpironium bromide in Korea, China and
certain other Asian countries. Under the sublicense agreement
with Kaken there are royalties and sales-based milestone payments
due to Brickell.
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. Sofpironium bromide is
not approved for use in any country at this time.
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 hyperhidrosis2,3. Primary 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 individuals2,3.
Additional information can be found on the International
Hyperhidrosis Society website: https://www.sweathelp.org/.
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 http://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 United States 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 changes, unanticipated demands on cash
resources, any disruption to our business caused by the current
COVID-19 pandemic, and 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 http://www.sec.gov (or at http://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
1 Change in the total GSP mean value for both axillae from
baseline to EOT is one of the co-primary efficacy endpoints
required by FDA for Brickell’s prospective U.S. Phase 3 pivotal
trials.
2 Doolittle et al. Hyperhidrosis: an update on prevalence and
severity in the United States. Arch Dermatol Res 2016; 308:
743-749.
3 Fujimoto et al. Epidemiological study and considerations of
focal hyperhidrosis in Japan. J Dermatol 2013; 40: 886-90.
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