325 subjects enrolled across the United States and Japan in the first Phase III clinical trial for the treatment of warts in children and adults.
Results from the CFW-3A trial are expected by the end of 2025.
Nielsen BioSciences, Inc. (“Nielsen”), a privately-held, San Diego-based biopharmaceutical company, announced the final patient has been successfully enrolled in CFW-3A – A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of CANDIN® (Candida albicans Skin Test Antigen for Cellular Hypersensitivity) for the Treatment of Common Warts (Verruca vulgaris) in Adolescents and Adults. CANDIN is not currently approved for the treatment of common warts.
“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,” said Sandra Johnson, MD, FAAD, Dermatologist from Fort Smith Arkansas and one of the principal investigators of this clinical trial. “We look forward to the conclusion and analysis of this data to hopefully improve the treatment of common warts in adolescents and adults.”
“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,” said H. Stewart Nielsen, Jr., Ph.D., Vice Chairman and Founder of Nielsen.
During the trial, participants will receive an injection of either Nielsen’s purified candida antigen (CANDIN) or a placebo every two weeks until either clinical clearance of the treatment wart is achieved, or a total of 10 injections have been administered. The primary endpoint of the trial is complete resolution of the treatment wart without recurrence at week 12. Results are expected by the end of 2025.
Nielsen is planning regulatory submissions in the US following the successful conclusion of the trial and has partnered with Maruho Co., Ltd. for the regulatory submission and commercialization of CANDIN in Japan. Nielsen is currently evaluating options and engaging in partnership discussions for commercialization in the US and other geographies.
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