Kaken Pharmaceutical Co. Ltd.
Kaken Pharmaceutical Co. Ltd.
10/14/2021 | Press release | Distributed by Public on 10/14/2021 02:12
Achievement of Primary Endpoints from U.S. Phase 3 Pivotal Clinical Studies of BBI-4000 for Treatment of Primary Axillary Hyperhidrosis
Kaken Pharmaceutical Co., Ltd., ("Kaken", head office Bunkyo-ku, Tokyo; President and Representative Director, Hiroyuki Horiuchi) announced that, on October 7 (EST), Brickell Biotech, Inc. ("Brickell", head office Colorado, U.S.) released topline results from the two U.S. Phase 3 pivotal clinical studies of BBI-4000 (INN: sofpironium bromide) in subjects with primary axillary hyperhidrosis.
Both of the Co-primary efficacy endpoints demonstrated statistically significant differences between sofpironium bromide gel, 15% and placebo in both of the Phase 3 clinical studies conducted (primary efficacy endpoints were "proportion of subjects achieving at least a 2-point improvement in the HDSM-Ax score from baseline to end of treatment" and "change in gravimetric sweat production from baseline to end of treatment"). In addition, sofpironium bromide gel, 15% was generally well tolerated. For more details, please refer to "https://ir.brickellbio.com/news/detail/70/brickell-biotech-announces-positive-topline-results " for the original press release issued by Brickell.
In Japan, Kaken has been developing BBI-4000 since 2015 and launched BBI-4000 as ECCLOCK Gel 5% for the treatment of primary axillary hyperhidrosis in November, 2020.
About BBI-4000 (INN: sofpironium bromide)
BBI-4000 is a new chemical entity that belongs to a class of drugs called "anticholinergics," which exert their effect by blocking the action of acetylcholine, a molecule that transmits signals within the nervous system that are responsible for a range of bodily functions, including the activation of sweat glands.
About HDSM-Ax (Hyperhidrosis Disease Severity Measure - Axillary)
A new patient reported outcome measure on axillary hyperhidrosis
About Primary axillary hyperhidrosis
A condition that involves heavy sweating under the armpits caused by heat, stress, or occurring without such causes, and interferes with daily life and work.