Nielsen BioSciences has reached a significant milestone in its clinical development program, completing enrollment of 325 participants across the United States and Japan in a pivotal Phase 3 trial evaluating CANDIN for the treatment of common warts.
The CFW-3A trial, a randomized, double-blind, placebo-controlled study, marks the first Phase 3 investigation of CANDIN (Candida albicans Skin Test Antigen) for treating Verruca vulgaris in adolescents and adults. The study represents a novel approach to wart treatment, focusing on immunological response rather than traditional removal methods.
Novel Immunological Approach to Wart Treatment
"Warts are a cutaneous manifestation of human papilloma virus (HPV) infection. Therefore, an immunological therapy directed at eliminating the viral infection has the potential to be an improvement to removal of the wart versus acid, surgery, cryotherapy and other methods that can damage skin," explained H. Stewart Nielsen, Jr., Ph.D., Vice Chairman and Founder of Nielsen.
Trial Design and Treatment Protocol
The study protocol involves bi-weekly injections of either CANDIN or placebo, continuing until either clinical clearance is achieved or a maximum of 10 injections have been administered. The trial's primary endpoint focuses on complete resolution of the treatment wart without recurrence at week 12.
Principal investigator Sandra Johnson, MD, FAAD, a dermatologist from Fort Smith Arkansas, commented, "I am pleased that the study accomplished this important milestone. Candida albicans has been well studied, but this is the first time that a randomized controlled Phase 3 clinical study to investigate safety, efficacy and optimal dosing for the treatment of warts has been conducted."
Patient Population and Study Parameters
The trial includes participants aged 12 years and older with 3 to 20 common warts. This broad inclusion criteria allows for comprehensive evaluation of the treatment's efficacy across different age groups and wart presentations.
Commercial Strategy and Future Plans
Nielsen BioSciences is pursuing a multi-faceted commercialization strategy. The company plans to submit regulatory applications in the United States following successful trial completion. For the Japanese market, Nielsen has established a partnership with Maruho Co., Ltd. for regulatory submission and commercialization. The company is currently exploring partnership opportunities for other global markets.
CANDIN is currently FDA-approved as a skin test antigen for assessing cellular hypersensitivity to Candida albicans, but has not yet received approval for wart treatment in any jurisdiction. Final results from the Phase 3 trial are anticipated by the end of 2025, potentially marking a significant advancement in wart treatment options.
