Verrica Pharmaceuticals Announces Start of Phase 3 Trial for the Treatment of Molluscum Contagiosum

Verrica Pharmaceuticals Inc. recently announced Torii Pharmaceutical Co., Ltd. dosed the first patient in its Phase 3 trial of VP-102 (referred to as TO-208 in Japan) for molluscum contagiosum in Japan, triggering an $8-million milestone payment from Torii to Verrica.

“We are pleased to see Torii dose the first patient in its Phase 3 trial of VP-102 for the treatment of molluscum contagiosum in Japan,” said Ted White, Verrica’s President and Chief Executive Officer. “The prevalence of molluscum contagiosum in Japan is estimated at 1.6 million cases annually, and we look forward to continuing our partnership with Torii in the Japanese market to potentially address this unmet need.”

In March 2021 Torii exercised its option to acquire the exclusive license to develop and commercialize Verrica’s product candidates for the treatment of molluscum contagiosum and common warts in Japan. Under the terms of the License Agreement, Torii made up-front payments of an aggregate of $12.0 million (including the original cost of acquiring the option) with up to an additional $58 million in aggregate payments contingent on achievement of specified development, regulatory, and sales milestones, in addition to tiered transfer price payments for supply of product in the percentage range of the mid-30s to the mid-40s of net sales. Torii is responsible for all development activities and costs in support of obtaining regulatory approval in Japan.

Verrica’s lead product candidate, VP-102, is a proprietary drug-device combination product that contains a GMP-controlled formulation of cantharidin (0.7% w/v) delivered via a single-use applicator that allows for precise topical dosing and targeted administration. VP-102 could potentially be the first product approved by the FDA to treat molluscum contagiosum — a common, highly contagious skin disease that affects an estimated 6 million people in the US, primarily children. If approved, VP-102 will be marketed in the United States under the conditionally accepted brand name YCANTH. In addition, Verrica has successfully completed a Phase 2 study of VP-102 for the treatment of common warts and a Phase 2 study of VP-102 for the treatment of external genital warts.

There are currently no FDA-approved treatments for molluscum, a highly contagious viral skin disease that affects approximately 6 million people — primarily children — in the US. Molluscum is caused by a pox virus that produces distinctive raised, skin-toned-to-pink-colored lesions that can cause pain, inflammation, itching and bacterial infection. It is easily transmitted through direct skin-to-skin contact or through fomites (objects that carry the disease like toys, towels or wet surfaces) and can spread to other parts of the body or to other people, including siblings. The lesions can be found on most areas of the body and may carry substantial social stigma. Without treatment, molluscum can last for an average of 13 months, and in some cases, up to several years.

Verrica is a dermatology therapeutics company developing medications for skin diseases requiring medical interventions. Verrica’s late-stage product candidate, VP-102, is in development to treat molluscum, common warts and external genital warts, three of the largest unmet needs in medical dermatology. Verrica is also developing VP-103, its second cantharidin-based product candidate, for the treatment of plantar warts. The Company has also entered a worldwide license agreement with Lytix Biopharma AS to develop and commercialize LTX-315 for dermatologic oncology conditions. For more information, visit www.verrica.com.