Brickell Biotech Announces Initiation of U.S. Phase 3 Program Evaluating Sofpironium Bromide Gel, 15% for the Treatment of Primary Axillary Hyperhidrosis
Primary axillary hyperhidrosis is estimated to affect over 10 million people in the U.S.
Sofpironium bromide is a retrometabolically designed investigational new chemical entity
BOULDER, Colo., Oct. 06, 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, announced today the initiation of its first pivotal U.S. Phase 3 clinical study evaluating sofpironium bromide gel, 15% as a potential treatment for primary axillary (underarm) hyperhidrosis (“Cardigan I Study”).
“This continues to be an exciting time for Brickell, with initiation of our first pivotal U.S. Phase 3 study coming just on the heels of the regulatory approval in Japan of sofpironium bromide gel, 5% for the treatment of primary axillary hyperhidrosis,” commented Robert Brown, Chief Executive Officer of Brickell. “The start of the Cardigan I Study is an important step towards achieving our goal of developing a potentially best-in-class treatment to improve the lives of millions of patients suffering with primary axillary hyperhidrosis in the U.S. We look forward to providing updates on the progress of our Phase 3 program later this year, including the initiation of the second pivotal U.S. Phase 3 clinical study (Cardigan II).”
The Cardigan I Study, which is expected to enroll up to 350 subjects aged 9 years and older with primary axillary hyperhidrosis, is a multicenter, randomized, double-blinded, vehicle (placebo)-controlled Phase 3 study to evaluate the safety and efficacy of topically applied sofpironium bromide gel, 15%. Subjects will apply the investigational product once daily at bedtime to their underarms for 6 consecutive weeks, with a 2-week post-treatment follow-up. The co-primary efficacy endpoints include the proportion of subjects achieving at least a 2-point improvement on the Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax) scale, a proprietary and validated patient-reported outcome measure, and change in gravimetric sweat production (GSP), each from baseline to end of treatment (EOT). In addition, safety and tolerability assessments will be performed throughout the study.