Brickell Biotech Aces Pivotal Sofpironium Trials In Patients With Excessive Underarm Sweating

Brickell Biotech Inc BBI has announced positive topline results from the Phase 3 pivotal Cardigan I and Cardigan II studies of sofpironium bromide gel for primary axillary hyperhidrosis (excessive underarm sweating).
The Company plans to file an FDA marketing application in mid-2022.
In Cardigan I trial (n=350), the proportion of subjects achieving at least a 2-point improvement on disease severity measure was 49.3% for the sofpironium bromide gel group vs. 29.4% for the vehicle.
The change in gravimetric sweat production (GSP) was -129.5 mg vs. -99.3 mg.
In the Cardigan II trial (n=351), 63.9% vs. 47% and -145.9 mg vs. -131.7 mg for disease severity and GSP, respectively.
In the Cardigan I and II studies, sofpironium bromide gel 15% was generally well-tolerated.
The Treatment-Emergent Adverse Events were mild or moderate in severity and transient in nature.
Overall, 89% of patients randomized to sofpironium gel 15% in the studies completed the full six weeks of treatment.
Brickell's management will host a webcast and conference call today at 8:30 a.m. ET.
Related: Brickell Biotech Acquires Rights To Candidate For Autoimmune Diseases.
Price Action: BBI stock is up 10.2% at $0.73 during the premarket session on the last check Thursday.