Verrica Pharmaceuticals (Nasdaq: VRCA) reports positive results for its pivotal Phase 3 CAMP-1 and CAMP-2 trials of lead product candidate, VP-102 at the American Academy of Dermatology (AAD) annual meeting Washington, DC from March 1-5. Both trials of VP-102 in patients with molluscum contagiosum (molluscum) successfully met their end points. TrialSite News breaks down this information for ease of review.
Who is Verrica Pharmaceuticals?
Verrica Pharmaceuticals Inc. is a pre-revenue, medical dermatology company committed to the development and commercialization of novel treatments that provide meaningful benefit for people living with skin diseases. Founded in 2013, the company’s late-stage product candidate, VP-102, is a potential first-in-class topical therapy for the treatment of molluscum contagiosum, a highly contagious viral skin infection affecting approximately six million people, primarily children, in the United States. There are currently no FDA-approved treatments for molluscum. Following positive topline results from two pivotal Phase 3 trials, a New Drug Application for VP-102 for the treatment of molluscum is planned for the second half of 2019. VP-102 is also currently in a Phase 2 trial for the treatment of common warts, with an additional Phase 2 trial planned in genital warts. A second product candidate (VP-103) is in pre-clinical development for plantar warts.
What is VP-102?
VP-102 is a proprietary investigational topical therapy in development to treat common skin indications including molluscum contagiosum and verruca vulgaris (common warts). VP-102 is a topical that is applied directly to lesions. It is designed to be convenient for both patients and practitioners.
What is Molluscum Contagiosum?
As reported by Mayo Clinic, Molluscum contagiosum (mo-LUS-kum kun-tay-jee-OH-sum) is a relatively common viral infection of the skin that results in round, firm, painless bumps ranging in size from a pinhead to a pencil eraser. If the bumps are scratched or injured, the infection can spread to surrounding skin. Molluscum contagiosum also spreads through person-to-person contact and contact with infected objects.
As of 2010, approximately 122 million people were affected worldwide by molluscum contagiosum (1.8% of the population).
Clinical Trials Descriptions
Sponsored by Verrica Pharmaceuticals, CAMP-1 is a Phase 3, randomized, double-blind, placebo-controlled, pivotal study to evaluate the safety and efficacy of VP-102 topical film-forming solution in subjects with Molluscum Contagiosum. VP-102 is applied once every 21 days for up to 4 applications, to treatable molluscum contagiosum (molluscum) lesions on subjects 2 years and older. Efficacy will be assessed as the proportion of subjects achieving complete clearance of all treatable molluscum lesions (baseline and new) on the Day 84 visit. The sponsor targeted 266 participants. Participating research sites can be viewed at the government-run ClinicalResearch.gov.
CAMP-2 is a Phase 3, randomized, double-blind, placebo-controlled, pivotal study to evaluate the safety and efficacy of VP-102 topical film-forming solution in subjects with Molluscum Contagiosum. VP-102 will be applied once every 21 days for up to 4 applications, to treatable molluscum contagiosum (molluscum) lesions on subjects 2 years and older. Efficacy will be assessed as the proportion of subjects achieving complete clearance of all treatable molluscum lesions (baseline and new) on the Day 84 visit.
What are the trial results?
As reported by their own press release, results from CAMP-1 and CAMP-2 showed 46 percent and 54 percent of subjects treated with VP-102, respectively, achieved complete clearance of all treatable molluscum lesions at the end of the trials (Day 84) versus 18 percent and 13 percent of subjects in the placebo groups (p<0.0001). By Day 84, VP-102 treated subjects had a 69 percent and 83 percent mean reduction in the number of molluscum lesions, a pre-specified endpoint, in CAMP-1 and CAMP-2 respectively, compared to a 20 percent increase and a 19 percent reduction for subjects on placebo.
VP-102 was well-tolerated in both trials, with no serious adverse events reported in VP-102 treated subjects. The most frequently reported adverse events were application site reactions that are well-known, reversible side effects related to the mechanism of action of cantharidin, a blistering agent, which is the active ingredient in VP-102. There were no treatment-related serious adverse events reported in CAMP-1 or CAMP-2.