Benzinga | Oct 7, 2021 06:56AM EDT

Brickell Biotech Announces Positive Topline Results, Achieving Statistical Significance On All Primary And Secondary Endpoints, From Both U.S. Phase 3 Pivotal Clinical Studies Of Sofpironium Bromide Gel, 15% In Primary Axillary Hyperhidrosis Patients

Brickell Biotech, Inc. ("Brickell") (NASDAQ:BBI), a clinical-stage pharmaceutical company striving to transform patient lives by developing innovative and differentiated prescription therapeutics for the treatment of dermatologic, autoimmune and other debilitating diseases, today announced positive topline results from the Phase 3 pivotal Cardigan I and Cardigan II studies, which evaluated sofpironium bromide gel, 15% as a once daily topical formulation in patients with primary axillary hyperhidrosis (excessive underarm sweating).

"We are excited to report the positive topline results from our pivotal Phase 3 clinical studies. These data are highly encouraging and further reinforce our belief that sofpironium bromide gel, 15% has the potential to become a best-in-class treatment option for the millions of patients suffering from primary axillary hyperhidrosis," said Robert Brown, Chief Executive Officer of Brickell. "The results from the Cardigan I and Cardigan II studies, along with all previously completed clinical studies, will form the basis for a U.S. NDA for sofpironium bromide gel, 15%, which we expect to submit to the FDA in mid-2022. We are tremendously appreciative of the collaborative and diligent efforts of our patients, study investigators, partners and employees who participated in or contributed to these studies. This was a huge team effort, and we are thankful to all of those involved in making our Phase 3 program a success."

"These data demonstrate that once-daily topical sofpironium bromide gel, 15% achieved early, sustained and significant improvements in primary axillary hyperhidrosis signs and symptoms consistent across all efficacy measures and was generally well-tolerated over six weeks of treatment," commented Stacy Smith, MD, a practicing dermatologist. "I feel privileged to have served as a principal investigator in the U.S. pivotal Phase 3 program. There is a real need for new and improved hyperhidrosis treatment options, and the results from these pivotal Phase 3 studies further support the potential for sofpironium bromide gel, 15% to become a first-line therapy of choice for patients with primary axillary hyperhidrosis."

The U.S. Phase 3 pivotal clinical program for sofpironium bromide gel, 15% was comprised of two pivotal clinical studies. The Cardigan I and Cardigan II studies enrolled 350 subjects and 351 subjects, respectively, who were nine years of age and older with primary axillary hyperhidrosis. The studies were multicenter, randomized, double-blinded, vehicle (placebo)-controlled, evaluating the efficacy and safety of topically applied sofpironium bromide gel, 15%. Subjects applied sofpironium bromide gel, 15% or placebo to their underarms once daily at bedtime for six consecutive weeks, with a two-week post-treatment follow-up. Additional details of the Cardigan I and II studies can be found on https://clinicaltrials.gov under identifiers NCT03836287 and NCT03948646, respectively.