Verrica Presents Promising Phase III Results for Molluscum & Genital Warts Treatment
They’re the unfortunate result of a virus and are best hidden until they slink back off to wherever they came from. Verrica Pharmaceuticals, which aims to expedite this process, presented positive safety and efficacy data this past weekend from two trials of its lead candidate for the treatment of a variety of warts and lesions.
Verrica, whose pipeline also consists of treatment candidates for plantar warts and non-melanoma skin cancer, is developing therapeutics for skin diseases that require medical intervention.
At the 2021 Winter Clinical Dermatology Conference, Verrica offered a poster with positive safety and efficacy results from the pivotal Phase III CAMP trials of VP-102, a proprietary drug-device combination product for the treatment of molluscum contagiosum, external genital warts (EGW), and common warts.
Molluscum contagiosum is a common, highly contagious viral disease affecting around six million people – largely children – in the U.S per year. Caused by a pox virus, it is characterized by raised, skin-toned, and pink-colored lesions that can lead to pain, inflammation, itching, and bacterial infection. Without treatment, the molluscum can stick around for 13 months, and potentially even longer.
VP-102, which has the potential to be the first product approved by the FDA for the treatment of molluscum contagiosum, contains a GMP-controlled formulation of cantharidin (0.7% w/v), which is delivered via a single-use applicator that allows for precise topic dosing and targeted administration.
“We are pleased to present further positive data supporting VP-102 as a potentially safe and efficacious treatment for molluscum,” said Gary Goldenberg, M.D., Chief Medical Officer at Verrica. “VP-102, our lead candidate, continues to demonstrate positive results as we advance development of the program in molluscum, external genital warts, and common warts, three of the largest unmet needs in medical dermatology.”
In Pivotal Phase III CAMP trials for molluscum contagiosum, complete clearance rates for baseline and new upper and lower extremity lesions were significantly better statistically when compared to the vehicle.
For participants being treated for lesions in the upper extremities – including the head and neck, back and buttocks, and chest and abdomen – these results were achieved beginning after the first treatment and throughout to the End of Study (EOS) visit. For participants with lesions on the lower extremities, complete clearance rates compared to the vehicle were achieved after two treatments through to the EOS visit.
Results from the Phase II CARE-1 study of VP-102 in external genital warts were also hopeful, showing statistically significant higher complete clearance rate of all warts compared to the control at the first visit (Day 63), as well as at the end of treatment (Day 84).
VP-102 is currently under U.S. Federal Drug Administration (FDA) review, and if approved, will be marketed under the conditionally accepted brand name, YCANTH™.