TO-208, known as VP-102 in the US and marketed under the brand name YCANTH, contains cantharidin as its active ingredient.
A Phase III clinical trial was conducted in Japan, involving subjects aged two years and above with molluscum contagiosum. In the trial, the therapy demonstrated efficacy over the control vehicle meeting its primary endpoint. It also demonstrated a safety profile consistent with the previous US studies, with no tolerability issues reported for the application.
In March 2021, Torii and Verrica Pharmaceuticals entered into an exclusive license agreement to develop and commercialise TO-208 for the treatment of molluscum and common warts in Japan.
This strategic partnership has led to the potential introduction of a new therapeutic option in the Japanese market, pending regulatory approval.
Verrica Pharmaceuticals has already received manufacturing and marketing approval for VP-102 in the US in July last year.
Since August last year, YCANTH has been available in the US market, where it stands as the first and only Food and Drug Administration (FDA)-approved product for molluscum contagiosum treatment in both adults and children over the age of two.
The drug-device combination product includes a single-use applicator for precise dosing.
In addition to its use for molluscum contagiosum, VP-102 has undergone a Phase II clinical trial to treat common warts and another Phase II study for external genital warts in the US, indicating the potential for broader therapeutic applications.
Verrica CEO and president Jayson Rieger said: “Torii continues to be an outstanding partner in advancing TO-208 for the treatment of molluscum, and today’s NDA submission represents the next critical milestone towards bringing to market the first therapeutic for addressing this indication in Japan.
“With an estimated prevalence of approximately 1.6 million cases, molluscum represents a large and underserved patient population in Japan, and we believe Torii’s therapeutic expertise and commercial infrastructure in dermatology will maximise the opportunity to address this significant unmet need.”