Phase III CAMP-1 and 2 trials of VP 102 meet primary endpoint in molluscum contagiosum.- Verrica Pharma.
Verrica Pharmaceuticals announced positive topline results from its Phase III CAMP-1 and CAMP-2 pivotal trials with VP 102 (cantharidin 0.7%) for the treatment of molluscum contagiosum (molluscum). Molluscum is a highly contagious skin disease affecting primarily children, with no current FDA approved treatment. Both clinical trials evaluated the safety and efficacy of VP 102, a proprietary drug-device combination containing a novel topical solution of 0.7% cantharidin, compared to placebo.
In each trial, VP 102 exhibited a clinically and statistically significant proportion of subjects demonstrating complete clearance of all treatable molluscum lesions versus placebo. VP 102 was well-tolerated in both trials, with no serious adverse events reported in VP 102 treated subjects. CAMP-1 and CAMP-2 enrolled 528 subjects in total and were conducted at 31 centers in the United States. The trials evaluated the safety and efficacy of VP 102 compared to placebo in subjects 2 years of age and older with molluscum contagiosum. Complete clearance was evaluated through assessment of lesion number at study visits over 12 weeks.
Results from CAMP-1 and CAMP-2 showed 46% and 54% of subjects treated with VP 102, respectively, achieved complete clearance of all treatable molluscum lesions at day 84 versus 18% and 13% of subjects in the placebo groups (p<0.0001). by the end of the trials (day 84), vp 102 treated subjects had a 69% and 83% mean reduction in the number of molluscum lesions, a pre-specified endpoint, in camp-1 and camp-2, respectively, compared to 20% and 19% for subjects on placebo. consistent with the results from the phase ii clinical trials, vp 102 was also well-tolerated in the phase iii trials, with side effects that were primarily mild to moderate.>0.0001).>