The phase 3 CAMP-1 and CAMP-2 clinical trials evaluating VP-102 for the treatment of molluscum contagiosum demonstrated clinical and statistical significance.
Lawrence F. Eichenfield, MD
Positive results from 2 of Verrica Pharmaceuticals’s pivotal phase 3 trials evaluating VP-102 for the treatment of patients with molluscum contagiosum (molluscum) demonstrated clinical and statistical significance for the 6 million individuals living with the highly contagious skin disease that still has no approved treatments from the US Food and Drug Administration (FDA).
“Molluscum is an incredibly common condition in childhood and can be incredibly distressing for patients and their families due to irritation, inflammation, co-infection in family members, secondary bacterial infections, and persistence [that can last] for years,” investigator Lawrence F. Eichenfield, MD, told MD Magazine®. “There is no standard intervention—and cantharadin is not well studied nor approved for treatment.”
In the randomized, double-blind, multicenter, placebo-controlled phase 3 CAMP-1 and CAMP-2 trials, investigators compared VP-102— a proprietary drug-device combination containing a novel topical solution of .7% cantharidin—to placebo in patients with molluscum.
Collectively, CAMP-1 and CAMP-2 enrolled 528 patients aged 2 years older with molluscum contagiosum at 31 centers in the United States. Over 12 weeks, assessments of lesion number at study visits evaluated complete clearance.
CAMP-1 was facilitated under an FDA Special Protocol Assessment (SPA). Evaluation of the efficacy of dermal application of VP-102 relative to placebo served as the primary objective. Patients were treated once every 21 days for up to 4 applications and assessed for the completion of clearance of all treatable molluscum lesions at Day 84 (Week 12/End of Study visit). Complete clearance at study visits on Days 21 (Week 3), 42 (Week 6) and 63 (Week 9) served as the secondary endpoints.
According to the results, 46% and 54% of patients treated with VP-102 achieved complete clearance of all treatable molluscum lesions at day 84 compared to 18% and 13% of subjects in the placebo groups (p<.0001). Additionally, patients treated with VP-102 experienced a 69% and 83% mean reduction in the number of molluscum lesions by the end of the trials (Day 84) compared to 20% and 19% for patients administered placebo.
“The data showed clearly the efficacy and consistent response to VP-102 versus the vehicle, with about 50% complete clearance at 12 weeks,” Eichenfield said. “These data open up the potential for VP-102 becoming a standard therapy for molluscum, allowing health care practitioners a reasonable and available effective therapy. There is currently no FDA-approved treatment for this cutaneous infection.”
The results reported in the phase 3 trials remained consistent with the results from the phase 2 clinical trials, including the safety profile. Favorable safety was observed with VP-102 treatment, with no treatment-related serious adverse events reported. Application site reactions and reversible side effects related to the mechanism of action of cantharidin included the reported adverse events.
Looking forward, Eichenfield added, “This data set will be worked on in more detail, submitted to the FDA in support of potential approval of VP-102. In addition, we assume the data will be submitted for publication later in the year.”