Novan Inc., initiates B-SIMPLE4 pivotal phase III study of SB 206 for treatment of molluscum contagiosum.

Novan, Inc.announced the initiation of the B-SIMPLE4 pivotal Phase III clinical study of SB 206, a topical antiviral gel, for the treatment of molluscum contagiosum (“molluscum”). Clinical sites are now open for patient enrollment.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 750 patients (1:1 randomization), across 45 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). Topline results from the B-SIMPLE4 trial are anticipated late in the second quarter of 2021, subject to the targeted timing for completing enrollment and trial execution plan which have been and may be further impacted by the COVID-19 pandemic.. Based on guidance the Company received during its Type C meeting with the FDA and subsequently contained within the meeting minutes, Novan is conducting B-SIMPLE4 a pivotal Phase III trial, which if successful, could be supported by the previously completed B-SIMPLE2 trial in a future New Drug Application (“NDA”). There are currently no FDA-approved therapies for the treatment of molluscum. Treatment choices for patients include in-office and often painful, physician-administered scraping, freezing, burning and blistering treatments. The only other choices, which lack proven clinical efficacy and unknown safety profiles, are off-label prescriptions and over-the-counter treatments. The Company believes that SB 206 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.