Positive results presented from CAMP-1 and CAMP-2 phase III trials of VP 102 in patients with molluscum contagiosum
Verrica Pharmaceuticals Inc. presented data from the company’s pivotal Phase III CAMP-1 and CAMP-2 trials of lead product candidate, VP 102, at the American Academy of Dermatology (AAD) annual meeting being held in Washington, DC from March 1-5. Both trials of VP 102 in patients with molluscum contagiosum (molluscum) successfully met their primary endpoints. In each trial, a clinically and statistically significant proportion of patients treated with VP 102 demonstrated complete clearance of all treatable molluscum lesions in 12 weeks.
On average, molluscum can take approximately 13 months to resolve without treatment, and in some cases can remain unresolved for several years. The CAMP-1 and CAMP-2 data were presented by Dr. Eichenfield during the Late-Breaking Research: Clinical Studies/Pediatric Session on Saturday, March 2 at 5:10 p.m. EST.
The two randomized, double-blind, multicenter, placebo-controlled trials evaluated the efficacy of dermal application of VP 102 compared to placebo in subjects with molluscum. In total, the trials enrolled 528 subjects two years of age and older with molluscum at 31 centers in the United States. Subjects were treated once every 21 days with topical solution of 0.7% cantharidin for up to four applications. Complete clearance of molluscum lesions was evaluated by assessment of the number of lesions at study visits over 12 weeks. 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. Verrica previously announced topline results from both trials on 3 January 2019. Based on the positive results, the Company plans to submit a New Drug Application (NDA) for VP 102 in the second half of 2019. If approved, VP 102 would be the first FDA-approved treatment for molluscum contagiosum.
Comment: Molluscum is a highly contagious viral skin disease that typically presents with 10-30 lesions, which take more than a year on average to clear up without treatment and sometimes several years. Children most typically contract the pox virus infection, but it can be easily transmitted to adult caregivers. In the US, estimated prevalence is about 6 million cases annually and the standard treatment since 1950 has been with cantharidin, a toxic blistering agent derived from Chinese beetles that has never been approved in the US as a drug therapy.
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