Novan Initiates B-SIMPLE4 Pivotal Phase 3 Study of SB206 for Treatment of Molluscum - Seite 2

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 U.S. Food and Drug Administration (“FDA”) and subsequently contained within the meeting minutes, Novan is conducting B-SIMPLE4 a pivotal Phase 3 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 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.

About Molluscum

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. Infected children typically present with 10 to 30 painless, yet unsightly lesions, and, in severe cases, they can have around 100 lesions. Due to the largely pediatric nature of the disease, parents are the caregivers for these children, in most cases, and tend to seek treatment. There are no FDA approved therapies for molluscum, and, upon seeking treatment, caregivers are faced with potentially painful in-office, dermatologist-administered physical procedures or cantharidin, or recommended off-label prescriptions and over-the-counter products. More than half of the patients diagnosed with molluscum are untreated and over 30% of those treated receive an off-label prescription with no molluscum indication or proven clinical efficacy. The average time to resolution is 13 months, however, some children experience lesions that may not resolve in 24 months. Further dissemination of this highly-contagious disease is common, and transmission to other children living in the household is reported to be 41%. There is a significant unmet need in the molluscum treatment landscape.