BBI - Brickell Biotech completes patient enrollment in late-stage sweat disorder study
Brickell Biotech (BBI) announces the completion of patient enrollment in the Phase 3 pivotal Cardigan I study evaluating sofpironium bromide gel, 15% in patients with primary axillary (underarm) hyperhidrosis.Shares up more than 2% premarket.Hyperhidrosis is a debilitating condition where a person sweats beyond what is physiologically required for thermoregulation of the body.The company also said that another study ((Cardigan II)) testing the treatment has surpassed 50% enrollment.The co-primary efficacy endpoints of both studies 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.The company expects to announce topline results from both studies in the fourth quarter of 2021.
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Brickell Biotech completes patient enrollment in late-stage sweat disorder study