SB206, a topical antiviral gel for the treatment of viral skin infections, was studied for the treatment of molluscum contagiosum in our pivotal Phase 3 trial, B-SIMPLE4. SB206 demonstrated positive efficacy results, achieving statistical significance (p value <.0001) for the primary endpoint, complete clearance of all lesions at week 12, and was shown to have a favorable safety profile with no serious adverse events related to SB206 reported.
We are now working towards an NDA filing for SB206 for the treatment of molluscum contagiosum.
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.