-Investors are responding positively to the company announcing positive topline efficacy and safety results for the B-SIMPLE4 pivotal Phase 3 clinical study of SB206, a topical antiviral gel, for the treatment of molluscum contagiosum.
-Molluscum is known as a common contagious skin infection caused by the molluscipoxvirus, affecting about 6 million people in the U.S. annually, with the greatest incidence in children aged one to 14 years.
-B-SIMPLE4 is a multi-center, double-blind, randomized, vehicle-controlled study that exceeded the enrollment target by randomizing 891 patients (1:1 randomization) in the study, across 55 clinical sites. And patients were treated for up to 12 weeks with a follow-up visit at Week 24.
-The primary endpoint for the study is the proportion of patients with complete clearance of all treatable molluscum lesions at Week 12 (Intent-to-Treat or “ITT” population, where the analysis assumes that patients with missing data at Week 12 are considered treatment failures).
-There are currently no U.S. Food and Drug Administration (FDA) approved therapies for the treatment of molluscum. And the company believes that SB206 as a topical, at-home, self or caregiver-applied therapy with a rapid treatment benefit, if approved, would satisfy an important patient-care need for the treatment of molluscum.