Brickell Biotech Doses First Patient in Second U.S. Pivotal Phase 3 Clinical Study

Rhea-AI Summary

Brickell Biotech has initiated the Cardigan II study, a pivotal Phase 3 clinical trial for sofpironium bromide gel, 15%, targeting primary axillary hyperhidrosis. This study follows the launch of ECCLOCK in Japan by Kaken Pharmaceutical, marking the first global commercialization of sofpironium bromide. Topline results from both the Cardigan I and II studies are expected in Q4 2021, potentially leading to a New Drug Application in the U.S. The global prevalence of hyperhidrosis affects over 15 million in the U.S. alone, highlighting a significant market opportunity.

Positive

• Initiation of the Cardigan II study, expanding the Phase 3 clinical program.
• First global commercialization of ECCLOCK in Japan by Kaken Pharmaceutical.
• Potential for successful study results to lead to a New Drug Application in the U.S.

Negative

• None.

Topline results from the U.S. pivotal Phase 3 program anticipated in the fourth quarter of 2021

Sofpironium bromide gel, 5% (ECCLOCK^®) recently launched in Japan by development partner, Kaken Pharmaceutical

BOULDER, Colo., Dec. 07, 2020 (GLOBE NEWSWIRE) -- 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 dosing of the first patient in its second U.S. pivotal Phase 3 clinical study (“Cardigan II study”) evaluating sofpironium bromide gel, 15% in approximately 350 subjects aged nine and older with primary axillary (underarm) hyperhidrosis. Brickell’s U.S. Phase 3 program is comprised of two pivotal trials, the Cardigan I and Cardigan II studies, which are both currently enrolling patients. The Company expects to announce topline results from these two studies in the fourth quarter of 2021. If successful, the results from the studies are expected to form the basis of a prospective New Drug Application in the U.S. for sofpironium bromide gel, 15% for the treatment of primary axillary hyperhidrosis. Additional details of the Cardigan II study can be found on https://clinicaltrials.gov under identifier NCT03948646.

“We are excited to announce the initiation of the Cardigan II study, which is the second trial in our U.S. pivotal Phase 3 clinical program for sofpironium bromide gel, 15%,” said Deepak Chadha, Chief Research and Development Officer of Brickell. “This marks another important milestone for the Company, and we continue to be encouraged by the progress we are making with our Phase 3 program, particularly in light of the current environment. We look forward to providing enrollment updates for the Cardigan I and II studies in the coming months.”

On November 26, 2020, Brickell’s Japanese development partner, Kaken Pharmaceutical Co., Ltd. (“Kaken”) launched commercial sales of ECCLOCK^® in Japan for the once-daily treatment of primary axillary hyperhidrosis. This marks the first commercialization of sofpironium bromide worldwide. Under the sublicense agreement with Kaken, Brickell is entitled to receive sales-based milestone payments, as well as tiered royalties based on a percentage of net sales of sofpironium bromide gel in Japan. Furthermore, Kaken has rights to develop and commercialize sofpironium bromide in South Korea, China, and certain other Asian countries, and Brickell is entitled to receive royalties based on a percentage of Kaken’s net sales in these countries.

About Sofpironium Bromide

Sofpironium bromide is a proprietary investigational 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 designed to exert their action locally and are potentially rapidly metabolized into a less active metabolite once absorbed into the blood. 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, 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 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 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, progress 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 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, 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, 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, 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.

¹Doolittle 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 is the Cardigan II study for Brickell Biotech (BBI)?

The Cardigan II study is a pivotal Phase 3 clinical trial evaluating sofpironium bromide gel, 15%, for treating primary axillary hyperhidrosis.

When will the topline results for the Cardigan studies be announced?

Topline results from the Cardigan I and II studies are expected to be announced in Q4 2021.

What is the significance of sofpironium bromide gel in the market?

Sofpironium bromide gel targets primary axillary hyperhidrosis, a condition affecting over 15 million people in the U.S., indicating a substantial market opportunity.

Who is Brickell's development partner for sofpironium bromide in Japan?

Brickell's development partner for sofpironium bromide in Japan is Kaken Pharmaceutical.

What are the expected outcomes of the clinical trials for Brickell Biotech (BBI)?

Successful outcomes from the clinical trials could lead to the submission of a New Drug Application in the U.S. for sofpironium bromide gel, 15%.