A Phase 2 Open-Label Study to Evaluate VP-102 for the Treatment of Molluscum Contagiosum

January 2021 | Volume 20 | Issue 1 | Original Article | 70 | Copyright © January 2021


Published online December 21, 2020

Sahra Niazi MDa,b, Bradford Brabec MDa,b, Luke Anschutz MDa,b, Cynthia Willson RN BSNc, Matthew Davidson PhDc, Patrick Burnett MD PhDc

aComplete Children’s Health, Pediatrics, Lincoln, NE
bMidwest Children’s Health Research Institute, Lincoln, NE
cVerrica Pharmaceuticals Inc., West Chester, PA



at baseline (mild effect on QoL) to 0.38 (no effect on QoL) at the EOS/day 84 visit.

DISCUSSION

This study represents the first clinical evaluation of VP-102, a propriety drug-device combination product containing 0.7% cantharidin (w/v), for the topical treatment of MC. While there are no approved treatments for this common skin infection in the US, compounded cantharidin has been used to treat MC and warts for more than 60 years.17 There are several limitations to the use of cantharidin for treatment of MC. Cantharidin’s access is limited due to restriction mandated by federal law, thus requiring physicians to obtain it outside the US or through compounding pharmacies. In addition, there are no data to support an optimized formulation or dosing regimen. Finally, the application and treatment schedule vary by practitioner, are inconsistent in previous studies, and the safety and efficacy of its use in MC has not been proven in large trials.16

The clinical development of VP-102 addresses these issues by seeking FDA approval of a standardized, shelf-stable formulation of cantharidin delivered via a proprietary, single-use applicator. The small tip of the applicator is designed to improve safety and efficacy by targeting MC lesions and sparing surrounding healthy skin, while the gentian violet surgical dye in the solution may assist in reducing duplicative dosing of individual lesions in a single treatment. The single-use applicator may also reduce the potential for cross-contamination, as direct contact with the skin is not necessary for application, and the applicator is not to be used across multiple patients.

Systemic exposure to cantharidin was negligible in this pediatric patient population, as evidenced by 65/66 plasma samples being below the LLOQ. These findings and the incidence of AEs support the safety of VP-102 to treat MC in the pediatric population. Complete clearance of MC lesions was observed in 48.5% of all VP-102-treated subjects and VP-102 treatment reduced the number of lesions by an average of 90.4% at the EOS/day 84 visit compared to baseline. On the CDLQI, subjects showed an improvement in QoL from a mild effect of disease at baseline to no effect at the end of the study.

CONCLUSION

In conclusion, the results of this Phase 2 study suggest that large randomized clinical trials are warranted to compare topical VP-102 with a vehicle control in a diverse population of subjects with MC in order to fully evaluate the safety and efficacy of VP- 102.

DISCLOSURES

The trial and was sponsored by Verrica Pharmaceuticals Inc. Drafting of the manuscript and creation of the figures were funded by Verrica Pharmaceuticals. Drs. Niazi, Brabec, and Anschutz served as clinical study investigators on the trial and received funding to complete the study. Dr. Davidson, Dr. Burnett, and Ms. Willson were employees and stockholders with Verrica Pharmaceuticals Inc. at the time of the study. Dr. Davidson holds the following patents related to the study: WO2018226894A1, WO2018232277A1, WO2016100732A3, WO2016118633A1, WO2015027111A1, W02014308690.

ACKNOWLEDGMENT

We thank the subjects and caregivers who were a part of the study, as well as Dr. Jessica McLin (Versant Learning Solutions, LLC) for her assistance with drafting the manuscript and figures, and Dr. Melissa Olivadoti for her assistance in coordinating author reviews and editorial changes.

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AUTHOR CORRESPONDENCE

Cynthia Willson RN BSN cwillson@verrica.com