Brickell Biotech Announces Publication of its U.S. Phase 2b Study Results for Sofpironium Bromide in Patients with Primary Axillary Hyperhidrosis in the Journal of the American Academy of Dermatology

BOULDER, Colo., Feb. 20, 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 that positive results from its Phase 2b study with sofpironium bromide in patients with primary axillary hyperhidrosis were published in the peer-reviewed Journal of the American Academy of Dermatology (JAAD). 

The paper, entitled “Efficacy and Safety of Topical Sofpironium Bromide Gel for the Treatment of Axillary Hyperhidrosis: A Phase 2, Randomized, Controlled, Double-Blinded Trial,” is now available online (Journal Pre-proof) at (https://doi.org/10.1016/j.jaad.2020.02.016) and will be published in a future print edition of JAAD.

Sofpironium bromide is an innovative, retro-metabolically designed, anticholinergic new molecular entity under investigation for the topical treatment of primary axillary hyperhidrosis. In this Phase 2b dose-finding study, sofpironium bromide elicited clinically and statistically significant sustained reductions in sweating severity and was well tolerated, suggesting that pivotal Phase 3 studies in the U.S. of this investigational drug are warranted.  Brickell and its Japanese partner, Kaken Pharmaceutical Co., Ltd. (“Kaken”) have conducted a range of clinical studies with sofpironium bromide in over 1,300 subjects, including a Phase 3 registration trial in Japan.

“We are encouraged by these Phase 2b study results and are pleased by the publication of these data in such a prestigious academic peer-reviewed journal,” said Deepak Chadha, M.S. M.B.A., Brickell’s Chief Research & Development Officer.  “These study results give us the confidence to continue to advance the development of sofpironium bromide.”

Stacy Smith, MD, an author, study investigator, and head of the California Dermatology and Clinical Research Institute, said, “The publication of these results are important to the millions of hyperhidrosis sufferers in the U.S. The dermatology community needs new treatment options to effectively manage hyperhidrosis patients and give them the quality of life they seek.”

Key findings from this study include:

• Topically applied sofpironium bromide gel, at concentrations of 5%, 10% and 15%, showed statistically significant differences relative to vehicle in axillary hyperhidrosis severity as demonstrated by improvement in Hyperhidrosis Disease Severity Measure–Axillary (HDSM-Ax; a proprietary validated patient report outcome measure), Hyperhidrosis Disease Severity Scale (HDSS), and modified Dermatology Life Quality Index-Axilla (DLQI-Ax). The HDSM-Ax and HDSS assessments showed improvements as early as the first post-baseline visit on day 8 and were sustained during the treatment period.  The DLQI-Ax was assessed at the baseline and end of treatment only.

• Although the Phase 2b study was not designed to detect treatment differences in Gravimetric Sweat Production (GSP), an objective measure of reduction in sweat production. sofpironium bromide gel, 15%, demonstrated a statistically significant result over vehicle.

• Across all dose groups, adverse events were predominantly mild or moderate in severity and transient in nature. Safety and tolerability assessments exhibited dose-related trends. The most common adverse events with sofpironium bromide were dry mouth and blurred vision, which are expected anticholinergic side effects.

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