FC21_FitzpatrickPoster_09.23.21 Pooled Results of VP-102 Safety and Efficacy in Phase 3 Trials for Molluscum Contagiosum by Fitzpatrick Skin Type (FST) Elaine Siegfried MD,1 Lawrence F. Eichenfield MD,2 Pearl Kwong MD,3 Seemal R. Desai MD,4,5 Susan Cutler,6 Cynthia Willson,6 Pamela Rumney,6 Christine Crosby,6 Jennifer Andres,6 Mark McBride7 1St. Louis University, St. Louis, MO; 2UC San Diego and Rady Children’s Hospital, San Diego, CA; 3Solutions Through Advanced Research, Jacksonville, FL; 4Department of Dermatology, The University of Texas Southwestern Medical Center, Dallas, Texas; 5Innovative Dermatology, Plano, Texas; 6Verrica Pharmaceuticals Inc, West Chester, PA; 7Instat Consulting, Inc., Chatham, NJ. • VP-102, a single-use proprietary drug-device combination product (cantharidin 0.7%), is under investigation for treatment of molluscum contagiosum (MC). In 2 phase 3 trials, 528 subjects ≥ 2 years with MC, were randomized (3:2) to receive topical application of VP-102 or vehicle. • While most subjects were Caucasian VP-102:vehicle (N=277:202 [89.4%:92.7%]), there was representation across all FSTs. FST is a tool which assesses skin burn propensity during phototherapy but can be misused to imply constitutive skin color/ethnicity.1 • Skin of Color patients with molluscum often experience pigmentary changes with or without treatment. However, FST has not been captured in molluscum treatment trials. • This post hoc analysis was designed to assess VP-102 efficacy (subjects achieving complete clearance (CC) (%)) and safety by FST group, compared to the overall study population. • VP-102 or vehicle was applied to all baseline and new lesions once every 21 days until CC, or up to 4 applications. • Subjects were evaluated at Days 21, 42, 63, 84. • Treatment emergent adverse events (TEAEs) were assessed throughout the study. INTRODUCTION METHODS Disclosures The studies were sponsored by Verrica Pharmaceuticals Inc. Editorial support was provided by Versant Learning Solutions and funded by Verrica Pharmaceuticals Inc. The authors have received the following from Verrica Pharmaceuticals: E. Siegfried: H, C; LF Eichenfield: H, C, S. P. Kwong: H, C; S. Desai: consultant; S. Cutler: E; C. Willson: E; P. Rumney: E; C. Crosby: E; J. Andres: E; M. McBride: consultant. H=honoraria; C=clinical funds; S=stocks; E=employee. CONCLUSION • VP-102 was safe and effective across all Fitzpatrick Skin Type groups, consistent with results from the overall study population. References 1. Ware O et.al. Racial Limitations of Fitzpatrick Skin Type. Cutis. 2020;105: 77-80. 2. Eichenfield L et.al. Pooled Results of Two Randomized Phase III Trials Evaluating VP-102, a Drug-Device Combination Product Containing Cantharidin 0.7% (w/v) for the Treatment of Molluscum Contagiosum. Am J Clin Dermatol. 2021. Mar;22(2): 257-265. DEMOGRAPHICS & MEDICAL HISTORIES RESULTS Baseline Characteristics Molluscum Medical Histories 0% 10% 20% 30% 40% 50% 60% 5.9 7.8 16.7 5.1 1.9 10.9 19.9 19.0 7.6 5.8 5.7 25.7 34.3 23.8 15.2 6.7 11.4 50.6 52.4 25.7 VP-102: Type I or II Vehicle: Type I or II Vehicle: Type III or IV Vehicle: Type V or VI VP-102: Type III or IV VP-102: Type V or VI 13.9 13.5 48.5 0.0 Visit 2 (Day 21) Visit 3 (Day 42) Visit 4 (Day 63) EOS Visit (Day 84) Co m pl et e Cl ea ra nc e (% ) EOS=end of study. • A significantly higher percentage of subjects achieved CC in the VP-102 group than with vehicle at Day 84; VP-102 vs. vehicle (50% vs. 15.6%) (p<0.0001). • Mean percent change from baseline in MC lesion counts decreased 76% for VP-102 and 0.3% for vehicle at Day 84 (p<0.0001). • The most common TEAEs in the VP-102 group were application site blistering, pruritus, pain, and erythema, which were generally mild or moderate in severity.2 EOS=end; ERT=evaluation of response to treatment. Dermatology Exam Treatment ApplicationERT CAMP 1 (N=266) & Two Randomized, Vehicle-Controlled, Double-Blind Phase 3 Trials 12 Weeks, VP-102:Vehicle (3:2 randomization) VP-102 CAMP 1 n=160 CAMP 2 n=150 Vehicle CAMP 1 n=106 CAMP 2 n=112 Visit 1 (Day 1) Visit 2 (Day 21) +24-hrs Visit Visit 3 (Day 42) Visit 4 (Day 63) EOS Visit (Day 84) CAMP 2 (N=262) VP-102 (n=311) Vehicle (n=216) Age (years) Mean (SD) 7.5 (6.7) 6.8 (5.8) Median (Range) 6.0 (2–60) 6.0 (2–54) Male 156 (50.2) 111 (51.4) Race or Ethnic Group - no. (%) White 277 (89.1) 201 (93.1) Black or African American 14 (4.5) 7 (3.2) Asian 6 (1.9) 1 (0.5) American Indian/Alaskan Native 0 1 (0.5) Other 14 (4.5) 6 (2.8) Gender - no. (%) Fitzpatrick Skin Type - No. (%) II I III IV V VI 20 (6.5) 81 (26.1) 8 (3.7) 71 (32.6) 97 (31.3) 69 (22.3) 70 (32.1) 34 (15.6) 33 (10.6) 9 (2.9) 32 (14.7) 3 (1.4) VP-102 (n=311) Vehicle (n=216) Baseline Lesion Count Mean (SD) 20.4 (23.0) 22.6 (22.3) Median (Range) 12.0 (1–184) 16.0 (1–110) Atopic Dermatitis (AD) - no. (%) History or Active AD 50 (16.1) 35 (16.2) Active AD* 23 (7.4) 20 (9.3) Complete Lesion Clearance by Fitzpatrick Skin Type (Pooled IIT Population) • Study included 180 subjects with FST I or II (n=101 VP-102; n=79 vehicle), 270 with FST III or IV (n=166 VP-102; n=104 vehicle), and 77 with FST V or VI (n=42 VP-102; n=35 vehicle). • CC of MC lesions across FST groups was 48.5%, 50.6%, 52.4% for types I/II, III/IV, and V/VI when treated with VP-102 and 13.9%, 13.5%, and 25.7% in vehicle group, respectively (p<0.0001 for types I/II and III/IV, and p=0.0008 for type V/VI). • The incidence of TEAEs by FST subgroup was similar to the overall study population.