Brickell Biotech Inc. (NASDAQ: BBI) has announced promising top-line data from the third phase crucial Cardigan I and Cardigan II trials which enrolled 350 and 351 subjects each above nine years. The studies assessed sofpironium bromide gel, 15%, as a once per day topical formulation in patients having primary axillary hyperhidrosis.
Brickell reports positive Phase 3 clinical studies data.
CEO Robert Brown said, “We are excited to report the positive top-line 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.”
Brown added, “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.”
Sofpironum bromide gel improved primary axillary hyperhidrosis signs
Commenting on the positive data, dermatologist Stacy Smith noted, “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. 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.”