Brickell Biotech Announces Publication of Japan Pivotal Phase 3 Study Results for Sofpironium Bromide Gel, 5% (ECCLOCK) in the Journal of Dermatology
Commercial launch of ECCLOCK in Japan currently underway by Development Partner, Kaken Pharmaceutical
BOULDER, Colo., Jan. 19, 2021 (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 the efficacy and safety results from the pivotal Phase 3 study conducted in Japan by its development
partner, Kaken Pharmaceutical Co., Ltd. (“Kaken”) were published in the peer-reviewed Journal of Dermatology1.
The paper, entitled “A phase 3, multicenter, randomized, double-blind, vehicle-controlled, parallel-group study of 5% sofpironium bromide (BBI-4000) gel in Japanese patients with primary axillary hyperhidrosis,” is available online in English at the Wiley Online Library (click here).
Kaken and Brickell first announced the release of the Japan pivotal Phase 3 study results in June 2020. Subsequently, Kaken received regulatory approval to manufacture and market ECCLOCK in Japan for the treatment of primary axillary hyperhidrosis in September 2020 and launched commercial sales in November 2020. Japan is the first country to approve sofpironium bromide, which also marks the first approval of a topical prescription product for the treatment of primary axillary hyperhidrosis in Japan.
“We are pleased to see Kaken continue to advance the commercialization of ECCLOCK in Japan, as a potential best-in-class treatment for patients with primary axillary hyperhidrosis,” said Deepak Chadha, Chief Research and Development Officer of Brickell. “The publication of Kaken’s pivotal Phase 3 study results in the highly regarded peer-reviewed Journal of Dermatology provides additional clinical support for sofpironium bromide and will be an important reference tool for treating dermatologists and physicians across Japan.”
In addition, Brickell recently initiated its U.S. pivotal Phase 3 clinical program evaluating sofpironium bromide gel, 15% for the treatment of primary axillary hyperhidrosis. Brickell expects to report topline data from the U.S. pivotal Phase 3 program in the fourth quarter of 2021.
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.