Novan (NOVN), today announced the first patient has been enrolled and dosed in its B-SIMPLE4 pivotal Phase 3 clinical study of SB206, a topical antiviral gel, for the treatment of molluscum contagiosum.
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.
I believe that the design of the B-SIMPLE4 study positions us well to fully evaluate SB206 for the treatment of molluscum, we are encouraged by the trends in efficacy as well as the safety profile SB206 has demonstrated to-date and look forward to continuing to advance development of this important program where there remains no FDA approved treatment.Elizabeth Messersmith, Ph.D, Senior Vice President & Chief Development Officer @ Novan (NOVN)
Completion of patient enrollment is targeted for the first quarter of 2021. Topline 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.
Novan (NOVN): What is Molluscum?
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.
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