Brickell Biotech Announces Presentation of US Phase 3 Open-Label Long-Term Safety Study Results for Sofpironium Bromide Gel at the Late-Breaking Research Program during American Academy of Dermatology’s 2021 VMX

Rhea-AI Summary

Brickell Biotech, Inc. (Nasdaq: BBI) announced that the results from its Phase 3 safety study of sofpironium bromide gel will be presented at the American Academy of Dermatology’s 2021 Virtual Meeting, taking place April 23-25, 2021. Sofpironium bromide is an investigational treatment for axillary hyperhidrosis, with its 5% formulation already approved in Japan. The company aims to address the significant market need, as hyperhidrosis affects around 15 million individuals in the U.S. alone.

Positive

• Results from the Phase 3 safety study of sofpironium bromide gel selected for presentation at a prominent dermatology conference.
• Sofpironium bromide gel, 5%, is already approved in Japan under the brand name ECCLOCK®.

Negative

• No negative aspects identified.

BOULDER, Colo., April 16, 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 results from the US Phase 3 open-label long-term (12-month) safety study of sofpironium bromide gel, 5% and 15% were selected for an oral presentation at the Late-Breaking Research Program during the American Academy of Dermatology’s (AAD) 2021 Virtual Meeting Experience (VMX) being held April 23– 25, 2021. Also, as one of the top twelve late-breaking research abstracts, Brickell has been invited to participate in a live Q&A session on April 24^th from 2:00 PM – 3:00 PM CT.

Details of the late-breaking research abstract presentation and the live Q&A session are as follows:

•	Oral Presentation Title:	A Multicenter, Randomized, Open-label, Phase 3 Long-term Safety Study (LTSS) of Topically Applied Sofpironium Bromide Gel, 5% and 15% in Subjects with Axillary Hyperhidrosis
•	On-Demand Presentation:	Available starting on Friday, April 23rd at 9:00 AM CT (10:00 AM ET)
•	Session Q&A:	Saturday, April 24th from 2:00 PM - 3:00 PM CT

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. pivotal Phase 3 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, AnGes 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.

                                 
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.

Brickell Investor Contact:
Dan Ferry
LifeSci Advisors
(617) 430-7576
daniel@lifesciadvisors.com

FAQ

What are the results of the sofpironium bromide Phase 3 study?

The results will be presented at the American Academy of Dermatology’s 2021 Virtual Meeting from April 23-25, 2021.

What is the significance of the Phase 3 study for Brickell Biotech?

It highlights the company's commitment to developing treatments for debilitating conditions like hyperhidrosis and engages the medical community through a live Q&A.

What condition does sofpironium bromide aim to treat?

Sofpironium bromide aims to treat axillary hyperhidrosis, a condition characterized by excessive sweating.

When will the presentation of the sofpironium bromide results take place?

The presentation will occur during the Late-Breaking Research Program at the AAD meeting on April 24, 2021.

What is the market impact of the sofpironium bromide presentation?

The presentation may enhance investor confidence and awareness of Brickell Biotech’s pipeline and potential market opportunities.