Berdazimer Gel Provides Complete Molluscum Clearance in 30% of Patients in 12 Weeks

New data from the phase 3 B-SIMPLE clinical trial show investigative molluscum contagiosum therapy berdazimer gel 10.3% provided an approximate 75% improvement in complete lesion clearance versus vehicle at 12 weeks.¹

The findings, presented during late-breaking sessions at the American Academy of Dermatology (AAD) 2023 Annual Meeting in New Orleans this weekend, supplement support for the agent that will be considered as the first potential drug for molluscum by the US Food and Drug Administration (FDA) in January 2024.²

The outcomes from the B-SIMPLE trial presented at AAD by study author John C. Browning showed the investigative gel provided complete lesion clearance in 30.0% of all treated patients by week 12, versus just 19.8% of patients receiving vehicle (odds ratio [OR], 1.75; 95% CI, 1.38 – 2.33).

What’s more, efficacy data among treated children aged 6 to <12 years old showed a 31.1% complete clearance rate associated with berdazimer gel, versus just 14.0% among the pediatric vehicle arm.

In an interview with HCPLive during AAD 2023, Mercedes Gonzalez, MD, a dermatologist with Pediatric Dermatology of Miami, discussed the potential value of a marketed topical, take-home agent like berdazimer gel for the highly common and uniquely burdensome molluscum.

“It’s estimated to affect about 6 million children in the United States, so there’s a huge unmet need,” Gonzalez said. “It’s something that bothers the children—however it does bother the entire family unit, because it is a very visible disease. With molluscum, you get those skin-colored umbilicated papules all over, and many times one means to many on the skin.”

Gonzalez additionally discussed research into the impact of molluscum on pediatric psychosocial wellbeing, citing patient issues with attending school and participating in recreational activities due to the condition.

Along with reviewing the promising efficacy from the B-SIMPLE data, Gonzalez discussed the prospect of berdazimer gel as a marketed drug—highlighting its ease of use and accessibility as a self-applied, take-at-home topical agent.

Regarding specific impact between pediatric versus adolescent patients, Gonzalez said tolerability may differ, as well as compliance. “Adolescents are going to be applying it themselves, versus in children, parents will be chasing them to apply this medication.”

There’s also a degree of concern behind the burden of treatment for patients who may be also treating a comorbid chronic skin disease like atopic dermatitis with topical drugs, Gonzalez said. That said, optimism remains high for clinicians and investigators seeking a breakthrough in treating molluscum.

“Many of our interventions at the present time are painful and they’re difficult to obtain,” Gonzalez said. “Having a new product possibly in the coming months is going to fill a very unmet need in the market.”

References

1. ^{Browning J et al. Efficacy of Berdazimer Gel 10.3% in the Treatment of Molluscum Contagiosum: Integrated Results from the B-SIMPLE Phase 3 Program. Paper presented at: American Academy of Dermatology 2023 Annual Meeting; March 17 – 21. New Orleans, LA. Accessed March 18, 2023.}
2. ^{Smith T. FDA Accepts Drug Application of Topical Antiviral Gel for Molluscum Contagiosum. HCPLive. Published March 7, 2023. Accessed March 19, 2023. https://www.hcplive.com/view/fda-accepts-drug-application-topical-antiviral-gel-molluscum-contagiosum}