Berdazimer Gel 10.3% (SB206)

In Development For The Treatment Of Molluscum Contagiosum
Berdazimer gel 10.3% (SB206), a topical antiviral gel for the treatment of viral skin infections, is currently in development for the treatment of molluscum contagiosum. In our pivotal Phase 3 trial, B-SIMPLE4, berdazimer gel 10.3% (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 berdazimer gel 10.3% (SB206) reported.

 

NDA for Berdazimer Gel, 10.3% (SB206) for Treatment of Molluscum Contagiosum Accepted for Review by U.S. FDA with a PDUFA Goal Date of January 5, 2024

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

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

U.S addressable
market of

～6 million²

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).