B-SIMPLE4: Primary Efficacy Endpoint – Complete Clearance of Lesions at Week 12
Note: Two previously completed Phase 3 studies posted directionally similar results and one or both will be included in the NDA submission as confirmatory to the above, B-SIMPLE4 efficacy results.
For more information about the B-SIMPLE4 pivotal Phase 3 trial, please visit clinicaltrials.gov and reference identifier: NCT04535531.
Molluscum contagiosum is a common, contagious skin infection caused by the molluscipoxvirus. There are currently 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.
Prevalence rate in children
0-16yrs in the U.S. is
5.1% – 11.5%¹
1.Prevalence in the US of 5.1% to 11.5% in children aged 0-16 years. (Fam Pract. 2014 Apr;31(2):130-6).
2.Molluscum Contagiosum – Epidemiology Forecast – 2028. Seven Major Markets (U.S., Germany, Spain, Italy, France, the United Kingdom, and Japan from 2017 – 2028).