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.
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