Brickell Biotech Announces Initiation of U.S. Phase 3 Program Evaluating Sofpironium Bromide Gel, 15% for the Treatment of Primary Axillary Hyperhidrosis - Seite 2
“The pivotal Phase 3 program is based on prior clinical development experience in which the investigational sofpironium bromide gel, 15% demonstrated statistically significant improvements in hyperhidrosis symptoms, and was safe and generally well tolerated as observed in the Phase 2 and 12-month long-term open label safety studies,” said Deepak Chadha, Brickell’s Chief Research & Development Officer. “The Company’s Phase 3 clinical program will be comprised of two pivotal trials, namely the Cardigan I and Cardigan II studies, which, if successful, will 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.”
Brickell’s Japanese development partner, Kaken Pharmaceutical Co., Ltd. (“Kaken”), received regulatory approval in September 2020 to manufacture and market sofpironium bromide gel, 5% (brand name: ECCLOCK) in Japan for the treatment of primary axillary hyperhidrosis. Japan is the first country to approve sofpironium bromide, with Kaken’s commercial launch expected there later this year. 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 Korea, China and certain other Asian 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 topically 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.
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