WEST CHESTER, Pa.—Just a couple days after the start of 2019, Verrica Pharmaceuticals Inc., a pharmaceutical company focused on identifying, developing and commercializing innovative pharmaceutical products for the treatment of skin diseases with significant unmet needs, announced positive top-line results from its Phase 3 CAMP-1 and CAMP-2 pivotal trials with VP-102 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-percent 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 vs. placebo. VP-102 was well tolerated in both trials, with no serious adverse events reported in VP-102 treated subjects.
“The top-line results from CAMP-1 and CAMP-2 validate our platform and bring us one step closer to our goal of providing patients with the first FDA-approved treatment for molluscum contagiosum, a significantly undertreated skin disease affecting an estimated six million people in the United States,” commented Ted White, president and CEO of Verrica. “We believe the efficacy and safety profiles of VP-102 observed in these two trials provide a strong foundation for our U.S. NDA, which we intend to submit in the second half of this year.”
The Phase 3 program for molluscum consisted of two clinical trials: CAMP-1 (study VP-102-101) and CAMP-2 (study VP-102-102). The two trials, which were identical in design, were randomized, double-blind, multicenter, placebo-controlled trials of VP-102 for the treatment of molluscum. CAMP-1 was conducted under an FDA Special Protocol Assessment. The primary objective of the trials was to evaluate the efficacy of dermal application of VP-102 relative to placebo, when treated once every 21 days for up to four applications, by assessing the proportion of subjects achieving complete clearance of all treatable molluscum lesions at day 84 (week 12/end of study visit). Secondary endpoints included the proportion of subjects with complete clearance at study visits on days 21 (week three), 42 (week six) and 63 (week nine).
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 percent and 54 percent of subjects treated with VP-102, respectively, achieved complete clearance of all treatable molluscum lesions at day 84, compared to 18 percent and 13 percent of subjects in the placebo groups. By the end of the trials, VP-102-treated subjects had a 69-percent and 83-percent mean reduction in the number of molluscum lesions in CAMP-1 and CAMP-2, respectively, compared to 20 percent and 19 percent for subjects on placebo.
“Molluscum contagiosum can often have a negative impact on the quality of life of affected children, exacerbated by the skin irritation and inflammation that can result as complications of the disease. The high lesion clearance rate demonstrated at day 84 for VP-102 compared to placebo in the Phase 3 trials is clinically significant and could potentially position VP-102 to become the standard of care for treating molluscum,” stated Dr. Lawrence Eichenfield, chief of pediatric and adolescent dermatology at Rady Children’s Hospital-San Diego and lead investigator for the VP-102 Phase 3 molluscum program.
Verrica plans to submit these and other data for presentation at future medical meetings and for publication in a peer-reviewed medical journal.