Novan Initiates B-SIMPLE4 Pivotal Phase 3 Study of SB206 for Treatment of Molluscum

- Clinical sites actively enrolling patients -

 - SB206, if approved, has the potential to meet an important need for the treatment of molluscum, an area with no current FDA-approved treatment -

MORRISVILLE, N.C. , Aug. 31, 2020 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (Nasdaq: NOVN), today announced the initiation of the B-SIMPLE4 pivotal Phase 3 clinical study of SB206, 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.

“Molluscum affects millions of people each year, a large percentage of those patients being children under the age of ten. SB206 represents, what I believe to be, an incredible opportunity to provide patients and caregivers an alternative treatment to the options currently available, including off-label prescriptions, procedures, and over-the-counter treatments with no clinical data that would support a molluscum indication and therefore have no proven clinical efficacy and an unknown safety profile. I believe SB206 has potential in addressing a significant unmet need in the treatment landscape of molluscum and if approved, would provide patients with a treatment benefit,” stated John Browning, M.D., F.A.A.D, F.A.A.P., MBA, Assistant Professor of Pediatrics and Dermatology and the Chief of Staff of Pediatric Dermatology at Texas Dermatology and Laser Specialists, and a Principal Investigator in the B-SIMPLE 4 clinical study.

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).

Paula Brown Stafford, Chairman, President and Chief Executive Officer of Novan commented, “We are pleased to initiate this study and are grateful for the dedication of our team who continue to navigate the commencement of a clinical trial in these unprecedented times with the COVID-19 pandemic. We worked diligently to partner with clinical sites that are actively seeing patients and are optimistic that we will reach our target to complete enrollment in the first quarter of 2021.”