Benzinga | Dec 7, 2020 07:32AM EST

Brickell Biotech Doses First Patient In Second US Pivotal Phase 3 Clinical Study Evaluating ECCLOCK

Topline results from the U.S. pivotal Phase 3 program anticipated in the fourth quarter of 2021

Sofpironium bromide gel, 5% (ECCLOCK(r)) recently launched in Japan by development partner, Kaken Pharmaceutical

BOULDER, Colo., Dec. 07, 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, today announced dosing of the first patient in its second U.S. pivotal Phase 3 clinical study ("Cardigan II study") evaluating sofpironium bromide gel, 15% in approximately 350 subjects aged nine and older with primary axillary (underarm) hyperhidrosis. Brickell's U.S. Phase 3 program is comprised of two pivotal trials, the Cardigan I and Cardigan II studies, which are both currently enrolling patients. The Company expects to announce topline results from these two studies in the fourth quarter of 2021. If successful, the results from the studies are expected to 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. Additional details of the Cardigan II study can be found on https://clinicaltrials.gov under identifier NCT03948646.

"We are excited to announce the initiation of the Cardigan II study, which is the second trial in our U.S. pivotal Phase 3 clinical program for sofpironium bromide gel, 15%," said Deepak Chadha, Chief Research and Development Officer of Brickell. "This marks another important milestone for the Company, and we continue to be encouraged by the progress we are making with our Phase 3 program, particularly in light of the current environment. We look forward to providing enrollment updates for the Cardigan I and II studies in the coming months."

On November 26, 2020, Brickell's Japanese development partner, Kaken Pharmaceutical Co., Ltd. ("Kaken") launched commercial sales of ECCLOCK(r) in Japan for the once-daily treatment of primary axillary hyperhidrosis. This marks the first commercialization of sofpironium bromide worldwide. 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 South Korea, China, and certain other Asian countries, and Brickell is entitled to receive royalties based on a percentage of Kaken's net sales in these countries.