Brickell Biotech Selected for a Late-Breaking Oral Presentation of US Phase 3 Pivotal Cardigan I and Cardigan II Study Results for Sofpironium Bromide Gel, 15% at the 2022 AAD Annual Meeting

Rhea-AI Summary

Brickell Biotech, Inc. (Nasdaq: BBI) announced that the results from its US Phase 3 pivotal studies, Cardigan I and Cardigan II, on sofpironium bromide gel (15%) for treating primary axillary hyperhidrosis will be presented at the AAD's Annual Meeting on March 26, 2022, in Boston, MA. This presentation will cover the efficacy of the gel in reducing excessive sweating. Brickell continues to focus on developing innovative therapeutics for autoimmune and inflammatory diseases, leveraging a strong pipeline and experienced management team.

Positive

• Results from the pivotal studies are being presented, indicating advancement in clinical research.
• Sofpironium bromide gel is designed to address an underserved market for excessive sweating.

Negative

• None.

BOULDER, Colo., March 10, 2022 (GLOBE NEWSWIRE) -- Brickell Biotech, Inc. (“Brickell” or the “Company”) (Nasdaq: BBI), a clinical-stage pharmaceutical company striving to transform patient lives by developing innovative and differentiated prescription therapeutics for the treatment of autoimmune, inflammatory and other debilitating diseases, announced today that results from the US Phase 3 pivotal Cardigan I and Cardigan II studies of sofpironium bromide gel, 15% in primary axillary hyperhidrosis patients were selected for an oral presentation at the Late-Breaking Research session during the American Academy of Dermatology’s (AAD) 2022 Annual Meeting, which is being held from March 25-29 in Boston, MA.

Presentation Details:

•   Oral Presentation Title:	Topically Applied Sofpironium Bromide Gel, 15% for the Treatment of Primary Axillary
	Hyperhidrosis: Results from the Cardigan I and Cardigan II Phase 3 Multicenter,
	Randomized, Placebo Controlled Trials
•   Date and Time:	Saturday, March 26, 2022 at 11:30 a.m. ET
•   Session:	S026 – Late-Breaking Research: Clinical Trials
•   Location:	Room 210A

About Brickell

Brickell Biotech, Inc. is a clinical-stage pharmaceutical company striving to transform patient lives by developing innovative and differentiated prescription therapeutics for the treatment of autoimmune, inflammatory, and other debilitating diseases. Brickell’s pipeline combines several development-stage candidates and a cutting-edge platform with broad potential in autoimmune and inflammatory disorders with a potential best-in-class, late-stage program for the treatment of primary axillary 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 pharmaceutical products that Brickell believes can meaningfully benefit patients who are suffering from chronic, debilitating diseases that are underserved by available therapies. 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, our strategy; future operations; future financial position; future liquidity; future revenue; projected expenses; results of operations; the anticipated timing, scope, design, progress, results, and/or reporting of data of ongoing and future non-clinical and clinical trials; intellectual property rights, including the validity, term, and enforceability of such; the expected timing and/or results of regulatory submissions and approvals; and prospects for commercializing any of Brickell’s product candidates, or research collaborations with, or actions of, its partners, including in Japan, South Korea, 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,” “might,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict,” “potential,” “will,” evaluate,” “advance,” “excited,” “aim,” “strive,” “help,” “progress,” “select,” “initiate,” “look forward,” “promise,” and similar expressions and their variants, as they relate to Brickell 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, research results and data that do not meet targets, expectations or regulatory approval requirements; ability to obtain adequate financing for product development, regulatory submissions, and any commercialization; ability to maintain and enforce intellectual property rights; potential delays or alterations in product development, trials of any type, and regulatory submission and reviews; changes in law or policy; regulatory agency feedback or requests; supply chain disruptions; unanticipated demands on cash resources; disruptions and negative effects related to the COVID-19 pandemic and the conflict in Ukraine; interruptions, disruption, or inability by Brickell or its partners to obtain or supply research material, raw materials, and/or product anywhere in the world; efforts to obtain and retain adequate pricing and adequate reimbursement and other insurance coverage for our products; the outcome of Brickell’s current and planned preclinical and clinical trials across our portfolio; 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, 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. Brickell specifically disclaims any duty or obligation to update forward-looking statements.

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

FAQ

What are the key findings from the Cardigan I and II studies on sofpironium bromide gel?

The Cardigan I and II studies illustrate the effectiveness of sofpironium bromide gel in treating primary axillary hyperhidrosis, with results being presented at the AAD Annual Meeting.

When will the results of the Phase 3 studies be presented?

The results will be presented on March 26, 2022, at 11:30 a.m. ET during the Late-Breaking Research session.

What is the significance of the results from the Cardigan studies for Brickell Biotech?

The results signify progress in clinical trials and reinforce Brickell's commitment to developing treatments for conditions like primary axillary hyperhidrosis.

What is sofpironium bromide gel being developed for?

Sofpironium bromide gel is being developed for the treatment of primary axillary hyperhidrosis, a condition characterized by excessive sweating.

What is Brickell Biotech's strategy moving forward?

Brickell aims to leverage its experienced management team to develop and commercialize innovative therapeutics for autoimmune and inflammatory diseases.