WEST CHESTER, PA — Verrica Pharmaceuticals Inc. (Nasdaq: VRCA), a dermatology therapeutics company developing medications for viral skin diseases requiring medical interventions, today announced the presentation of new pooled data from two analyses of the Phase 3 CAMP trials of VP-102 (cantharidin 0.7% topical solution),
Verrica’s lead product candidate for the treatment of molluscum contagiosum (molluscum). These data are available in poster format online by the American Academy of Dermatology for the 2020 annual meeting, which was previously scheduled for March 20-24 in Denver, Colorado.
A pre-specified exploratory analysis of pooled data demonstrated that, regardless of lesion count, all VP-102 quartiles had statistically significantly higher percentage of patients with complete clearance of all baseline and new lesions as compared to vehicle (p<0.05), and that complete clearance rates were similar across all VP-102 quartiles.
In this analysis, patients treated with VP-102, across all lesion count quartiles, were similar in baseline characteristics and molluscum medical histories. Participants were segmented by baseline lesion count: Quartile 1) 1-7 lesions (n=94); Quartile 2) 8-14 lesions (n=82); Quartile 3) 15-28 lesions (n=67); and, Quartile 4) 29-184 lesions (n=68). Mean age of patients was: Quartile 1) 9.0 years; Quartile 2) 7.5 years; Quartile 3) 6.0 years; and, Quartile 4) 6.7 years. Mean time since clinical diagnosis was: Quartile 1) 134.3 days; Quartile 2) 116.8 days; Quartile 3) 121.0 days; and, Quartile 4) 118.2 days. At baseline, the percentage of patients presenting with a history of atopic dermatitis (AD), or with active AD, included: Quartile 1) 8%; Quartile 2) 7%; Quartile 3) 16%; and, Quartile 4) 19%. Selected treatment-emergent adverse events at the application site were similar across quartiles with VP-102 treatment including vesicles, pain, scab, erythema, pruritus, discoloration, dryness, edema, erosion, and scarring.
“These data are important, as they show that VP-102 has the potential to effectively and safely treat molluscum patients – and achieve complete clearance – regardless of the number of lesions,” said Lawrence Eichenfield, MD, Chief of Pediatric and Adolescent Dermatology, Rady Children’s Hospital, San Diego, CA, and principal investigator of the VP-102 Phase 3 molluscum program. “Historically, patients with high lesion counts, a group addressed in this analysis, have been challenging to treat.”
The second abstract is a post-hoc analysis in which VP-102-treated subjects were categorized by those who achieved complete lesion clearance (CC) and those who did not (NC) by the end of study visit (EOS, Day 84), to compare demographics and outcomes between the groups, and identify characteristics potentially predictive of response to treatment with VP-102. The analysis demonstrated that in patients treated with VP-102, baseline demographics and medical histories were similar between the CC group and the NC group at EOS. Safety outcomes were similar in both groups, except for application site pain and pruritus (both were higher in the NC group). Baseline lesion count was not clinically different, and there was no difference in time since diagnosis between groups, age, gender, previous treatment, or atopic dermatitis history or status. These results demonstrated that any patient who fits the requirements of the study protocol and has similar characteristics could potentially achieve complete clearance of all baseline and new molluscum lesions after up to four treatments with VP-102.
“These two analyses of the Phase 3 CAMP trials add to the body of evidence that supports the safety and efficacy profile of VP-102,” said Ted White, President and Chief Executive Officer, Verrica. “In these analyses, we see clear evidence that regardless of how many lesions a patient has, or what their baseline characteristics may be, VP-102 has the potential to be a viable treatment option to help patients with molluscum achieve complete lesion clearance.”
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