SB206 - Molluscum and External Genital Warts

Novan is developing SB206 as a topical antiviral gel for the treatment of viral skin infections, with a current focus on the treatment of molluscum contagiosum, a contagious skin infection caused by the molluscipoxvirus, and external genital warts (EGW) caused by human papillomavirus (HPV). There are currently no FDA approved therapies for the treatment of molluscum. Caregivers are faced with potentially painful in-office, physician-administered treatments or off-label prescriptions with no molluscum indication, no proven clinical efficacy and tolerability issues. As a result of the inadequate treatment paradigm, over 50% of patients diagnosed with molluscum are untreated. SB206, if approved, could be a topical, at-home, caregiver-applied therapy with a rapid treatment benefit.

Phase 3 Molluscum Program Progresses Promising Topical Treatment

Novan has launched the two molluscum pivotal studies (B-SIMPLE1, B-SIMPLE2) in and key characteristics include:

  • Randomized, double-blind, vehicle-controlled pivotal trials with SB206 12% once-daily as the active treatment arm
  • Each pivotal trial is planned to enroll approximately 340 subjects aged 6 months and above at a 2:1 ratio
  • The primary endpoint for the trials is proportion of patients with complete clearance of all treatable molluscum lesions at Week 12.

Clinical Trial Results

In a Phase 2 dose-ranging trial for the treatment of molluscum, clinical trial results include: 

  • For the primary endpoint, 12% once-daily was the most effective dose with 42% (mITT, p<0.05) and 38% (ITT, p<0.05) complete clearance rates compared to 20% and 18% for vehicle, respectively.
  • For the secondary endpoint of mean percent change from baseline molluscum lesion count at each visit, patients treated with 12% once-daily experienced 29% (p<0.05), 37% (p<0.01), 56% (p<0.001) and 55% reductions in molluscum lesions at Week 2, 4, 8 and 12, respectively (mITT).
  • No quantifiable levels of systemic exposure detected for SB206 12% twice-daily or once-daily following 12 weeks of treatment.
  • The 12% once-daily treatment group had the lowest dropout rate out of all treatment groups, 9%, with 0 patients discontinuing treatment due to adverse event.

In a Phase 2 dose-ranging clinical trial for the treatment of external genital warts, clinical trial resutls include:

  • In the primary efficacy analysis, 33% of patients achieved complete clearance of baseline warts by week 12 when treated with SB206 12% once-daily, compared to only 4% of patients achieving complete clearance with vehicle once-daily (p=0.0099).
  • The proportion of subjects with complete clearance of all warts was 30% for SB206 12% once-daily and 4% for vehicle once-daily (p<0.02).
  • Once-daily treatment arms were generally well-tolerated, including the most effective dose, SB206 12% once-daily.

Preclinical Data

  • SB206 exhibited a dose responsive pharmacologic effect with complete inhibition of papilloma growth compared to topical imiquimod in an in vivo model.
  • NVN1000, the active pharmaceutical ingredient in SB206, exhibited a dose dependent decrease in HPV viral replication in human raft cell culture model.

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About Molluscum

Molluscum contagiosum is a contagious skin infection caused by the molluscipoxvirus. Molluscum affects approximately six million people in the U.S. annually. The greatest incidence is in children aged one to 14 years. The average time to resolution is 13 months, however, 13% of children experience lesions that may not resolve in 24 months. There is no FDA approved treatment for Molluscum. More than half of patients diagnosed with the infection are untreated. The majority of patients that receive treatment are treated with painful procedures and the remaining are often prescribed products indicated for the treatment of external genital warts.

About HPV

HPV refers to a large family of double-stranded DNA viruses that induce abnormal growths on the skin or mucosal surfaces. HPV affects nearly 80 million Americans, and an estimated 14 million new cases of the virus are reported each year, according to the Centers for Disease Control and Prevention, or CDC. The virus is typically transmitted via direct skin-to-skin contact through disruptions in the normal skin barrier. There are over 100 subtypes of the virus, characterized as low-risk or high-risk based on their cancer-causing potential. While low-risk variants of HPV typically are associated with two types of papillomas – common warts and genital warts – high-risk strains of the virus are associated with cervical intraepithelial neoplasia (CIN) and cervical cancers; high-grade anal intraepithelial neoplasia (HGAIN) and anal cancer; and, other cancers of the vagina, vulva, rectum and penis.