Brickell Biotech Announces Initiation of a Phase 1 Study of Sofpironium Bromide Gel in Primary Palmoplantar Hyperhidrosis Patients by its Development Partner, Kaken Pharmaceutical in Japan

BOULDER, Colo., June 24, 2021 (GLOBE NEWSWIRE) — Brickell Biotech, Inc. (“Brickell” or the “Company”) (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 its development partner, Kaken Pharmaceutical Co., Ltd. (“Kaken”), recently initiated a Phase 1 clinical study to assess the pharmacokinetics (PK) of sofpironium bromide gel in patients with primary palmoplantar hyperhidrosis (PPH) in Japan.

PPH is a common medical disorder of excessive sweating from the palms and soles that affects both adults and children. PPH is an extremely stressful and embarrassing dermatologic disorder that commonly interferes with daily life and can become socially and professionally disabling. In Japan, 5.33% and 2.79% of the population are estimated to be affected by primary palmar and plantar hyperhidrosis, respectively¹. There are currently no approved topical prescription treatment options for PPH in Japan.

“We are pleased to see Kaken initiate this Phase 1 clinical study to explore the PK, safety, and efficacy of sofpironium bromide gel in treating Japanese patients with PPH in less than a year after the launch of sofpironium bromide gel, 5% (ECCLOCK^®) for the treatment of primary axillary hyperhidrosis in Japan, as part of the life cycle management,” said Deepak Chadha, Chief Research and Development Officer of Brickell. “Depending on the outcome of the Phase 1 study, Kaken and Brickell will determine the next steps, if any, for the development of sofpironium bromide gel in PPH patients in their respective territories.”

In addition, Brickell is currently conducting its U.S. Phase 3 pivotal program for sofpironium bromide gel, 15% which is comprised of two pivotal clinical studies, Cardigan I and Cardigan II. Both randomized, double-blinded, placebo-controlled pivotal studies are evaluating sofpironium bromide gel, 15% vs. placebo (1:1 ratio) in approximately 350 subjects (per study) aged nine and older with primary axillary hyperhidrosis. Brickell expects to report topline results from the Cardigan I and II pivotal studies in the fourth quarter of 2021.

About Sofpironium Bromide

Sofpironium bromide is Brickell’s lead investigational product candidate and is a new chemical 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 intended to exert their action locally and are potentially rapidly metabolized into a less active metabolite once absorbed into the blood. Sofpironium bromide gel, 15% is currently being evaluated in a U.S. Phase 3 pivotal clinical program for the treatment of primary axillary hyperhidrosis, and sofpironium bromide gel, 5% is approved in Japan for the same indication under the brand name ECCLOCK^®. 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 debilitating, life-altering medical condition where a person sweats beyond what is physiologically required for thermoregulation of the body. More than 15 million people, or 4.8% of the population of the United States, and 12.76% of the population in Japan, are believed to suffer from hyperhidrosis^1,2. 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. 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 the development of innovative and differentiated prescription therapeutics for debilitating skin diseases with a focus on its lead asset sofpironium bromide for the treatment of hyperhidrosis. 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 and differentiated pharmaceutical products that Brickell believes can be successful in the marketplace and transform lives by solving currently unmet patient needs. For more information, visit https://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 ongoing and future clinical trials, intellectual property rights, including the validity, term and enforceability of such, the expected timing and/or results of regulatory approvals and prospects for commercializing any of Brickell’s product candidates, or research collaborations with its partners, 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,” “potential,” “look forward” and similar expressions and their variants, as they relate to Brickell, Kaken, or any of Brickell’s partners, 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, ability to maintain and enforce intellectual property rights, potential delays for any reason in product development and clinical trial enrollment, regulatory changes, supply chain disruptions, unanticipated demands on cash resources, any disruption to its business caused by the current COVID-19 pandemic, interruptions, disruption or inability by Kaken to supply and commercialize the product in Japan, or obtain or retain adequate pricing or reimbursement, the outcome of Brickell’s ongoing U.S. Phase 3 pivotal program on sofpironium bromide, and other risks associated with developing and obtaining regulatory approval for and commercializing product candidates.

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 https://www.sec.gov (or at https://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.

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1 Fujimoto et al. Epidemiological study and considerations of focal hyperhidrosis in Japan. J Dermatol 2013; 40: 886-90.
2 Doolittle et al. Hyperhidrosis: an update on prevalence and severity in the United States. Arch Dermatol Res 2016; 308: 743-749.

Brickell Investor Contact:

Dan Ferry
LifeSci Advisors
(617) 430-7576
daniel@lifesciadvisors.com