Brickell Biotech Reports Results from U.S. Phase 3 Open-Label, Long-Term Safety Study on Chronic Use of Sofpironium Bromide Gel as a Potential Treatment for Primary Axillary Hyperhidrosis
Brickell Biotech presented positive results from its Phase 3 ARGYLE study on sofpironium bromide gel for treating primary axillary hyperhidrosis. Over 48 weeks, the treatment was well-tolerated, with 86.1% of patients showing a one-point improvement in sweat severity. No serious adverse events were reported, and treatment-related adverse events decreased over time. Upcoming pivotal studies, Cardigan I and II, will further evaluate the 15% gel dose. Results may support a New Drug Application in the U.S. for this condition.
- Sofpironium bromide gel showed sustained efficacy with 86.1% of patients achieving a one-point improvement in sweat severity after 48 weeks.
- The treatment was well-tolerated, with most side effects being mild or moderate and transient.
- No treatment-related serious adverse events were reported throughout the study.
- Adverse events incidence decreased as patients acclimated to treatment over the study period.
- The incidence of treatment-emergent adverse events for the 15% dose was 50.8%, indicating a higher potential for adverse reactions compared to the 5% dose (22.5%).
Daily treatment with sofpironium bromide gel was generally well-tolerated over 48 weeks of treatment
Efficacy assessments showed a clinically meaningful and sustained improvement in sweat severity through the 48 weeks of treatment
Data presented today in a late-breaking oral presentation at AAD VMX 2021
Management to host an investor call today at 12:00 p.m. EDT
BOULDER, Colo., April 23, 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 results from its Phase 3 open-label, long-term safety study (“ARGYLE” or “LTSS”), which were also presented today in a late-breaking oral presentation at the American Academy of Dermatology’s (“AAD”) 2021 Virtual Meeting Experience (“VMX”). The ARGYLE study assessed the long-term safety and efficacy of topical, once-daily treatment with sofpironium bromide gel,
“We are pleased that the ARGYLE study results further strengthen the safety, tolerability and efficacy data previously observed in our Phase 2b study of sofpironium bromide gel.” said Deepak Chadha, Brickell’s Chief Research & Development Officer. “As was observed with earlier clinical studies, the majority of side effects were mild or moderate in severity and transient in nature. Sofpironium bromide gel,
“In this LTSS study, sofpironium bromide gel was generally well-tolerated with continued efficacy during 48 weeks in patients with primary axillary hyperhidrosis. In addition, we were pleased to see that the incidence of patients with any treatment-emergent adverse events decreased over time, as did the number of discontinuations,” commented Stacy Smith, MD, a practicing dermatologist and participating investigator in this study. “Taking into consideration that patients did not have the conventional option to acclimate to treatment prior to enrolling in this standalone long-term safety study, the observed safety profile is even more encouraging.”
ARGYLE: Phase 3 Open-Label Long-Term Safety Study Results
The ARGYLE study evaluated the long-term safety and efficacy of sofpironium bromide gel,
The treatment-related treatment-emergent adverse events (TEAEs) for sofpironium bromide gel,
With respect to studied efficacy, the
Overall, the safety, tolerability and efficacy results for sofpironium bromide gel,
Late-Breaking Oral Presentation at AAD VMX 2021
An on-demand video of the virtual late-breaking oral presentation by Dr. Smith will be available to attendees of the AAD VMX 2021 starting at 10:00 a.m. EDT. The presentation is titled, “A Multicenter, Randomized, Open-label, Phase 3 Long-term Safety Study (LTSS) of Topically Applied Sofpironium Bromide Gel,
Today’s Conference Call and Webcast Information
Brickell’s management will host a conference call geared toward industry and the investment community today at 12:00 p.m. EDT where Dr. Stacy Smith will discuss the ARGYLE study results, followed by a Q&A session. The conference call will be accessible to the public, and the dial-in number for the conference call is 1-877-705-6003 for domestic participants and 1-201-493-6725 for international participants, with Conference ID #13718742. A live webcast of the conference call can be accessed through the Investors tab on the Brickell Biotech website at https://www.brickellbio.com. A replay of the webcast also will be available on Brickell’s website in the Investors tab shortly after conclusion of the call and will be available for approximately 90 days.
U.S. Pivotal Phase 3 Cardigan I and Cardigan II Studies
The Company is currently conducting the U.S. Phase 3 Cardigan I and Cardigan II clinical studies evaluating sofpironium bromide gel,
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,
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
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, 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
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