Shares of Novan (NOVN) surged on market open when the company announced that it had exceeded enrollment of their B-SIMPLE4 Pivotal Phase 3 Study for SB206 for Treatment of Molluscum. If approved, this makes Novan the first in the world for a Molluscum treatment.
Molluscum contagiosum is a common, contagious skin infection caused by the molluscipoxvirus, affecting approximately six 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 expected to enroll approximately 850 patients (1:1 randomization), across approximately 50 clinical sites, who will be treated for 12 weeks with a follow-up visit at Week 24. The primary endpoint for the study is 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 assessed as treatment failures).
“Achieving 60% enrollment amidst the COVID-19 pandemic is a noteworthy accomplishment for our B-SIMPLE4 pivotal program and highlights the unmet need that exists for patients. We believe that SB206 has the potential to offer a solution to molluscum patients and we are encouraged by the overall enthusiasm we have seen for this study. I would like to take this opportunity to sincerely thank all the investigators and their staff, as well as the molluscum patients for their ongoing support and participation in the study,” commented Paula Brown Stafford, President and Chief Executive Officer of Novan.
Completion of patient enrollment is targeted for the first quarter of 2021. Topline efficacy results from the B-SIMPLE4 trial are anticipated in the second quarter of 2021, subject to the targeted timing and trial execution plan which have been and may be further impacted by the COVID-19 pandemic.
There are currently no FDA-approved therapies for the treatment of molluscum. The Company believes that SB206 as a topical, at-home, caregiver-applied therapy with a rapid treatment benefit, if approved, would satisfy an important patient-care need for the treatment of molluscum