Brickell Biotech, Inc. has initiated its first pivotal US Phase 3 clinical study evaluating sofpironium bromide gel, 15% as a potential treatment for primary axillary 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,” comments 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 multicenter, randomized, double-blinded, vehicle (placebo)-controlled Cardigan I Study is expected to enroll up to 350 subjects aged 9 years and older with primary axillary hyperhidrosis. Subjects will apply the investigational product once daily at bedtime to their underarms for six consecutive weeks, with a two-week post-treatment follow-up. The co-primary efficacy endpoints include the proportion of subjects achieving at least a two-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.

In Phase 2 and 12-month long-term open label safety studies, sofpironium bromide gel, 15% demonstrated statistically significant improvements in hyperhidrosis symptoms, and was safe and generally well tolerated.

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.