Phase III Trial Reports Positive Topline Results for Candin in Common Warts
Topline data from a completed phase III trial evaluating Candin® (Purified Candida albicans Antigen) demonstrated its potential effectiveness in the treatment and resolution of common warts (verruca vulgaris). The findings support further advancement of this immunotherapy-based approach for managing cutaneous warts.
The study analyzed patients 12 years of age and older following treatment with CANDIN or saline injection as placebo, analyzing a total of 325 patients in the US and Japan. The study successfully met its primary endpoint of the complete resolution of the treated wart without recurrence through 12 weeks post-injection. Secondary endpoints, including the number of injections to achieve clearance of the injected wart and clearance of all or greater than 50% of measured warts beyond the injected wart were also met, providing evidence of CANDIN’s systemic effect. The study also assessed scarring and skin discoloration, which are key concerns of patients and dermatologists when treating warts with traditional methods.
“The successful completion of this Phase 3 trial, the first ever placebo-controlled, randomized clinical trial for this HPV-driven skin condition, is a milestone for the company and for patients suffering from common warts who are in urgent need of new treatment options,” said Robert Esch, PhD, one of the co-authors of the study and a member of the Board of Directors at Nielsen Biosciences. “We extend our gratitude to both patients and investigators across the U.S. and Japan, whose time and commitment made this trial possible.”
“Our strategy to combine the US and Japan in one Phase 3 clinical trial was a success and we extend our deepest thanks to Maruho, our Japanese partner, for their confidence, efforts and support,” said David P. Burney, PhD, MBA, President and Chief Operating Officer at Nielsen BioSciences. “These positive Phase 3 trial results provide a compelling foundation for CANDIN to become the first approved therapeutic for the treatment of HPV-driven skin infections, and we look forward to continuing our advancement of this groundbreaking new treatment.”
Nielsen is currently completing the analysis of the full data set from the Phase 3 trial and its Clinical Study Report. The Company expects to file for approval with the U.S. Food and Drug Administration (FDA) in the second half of 2026. Nielsen is partnering with Maruho Co. Ltd, a leading dermatology-focused pharmaceutical company headquartered in Japan and exclusive licensee for the commercialization of CANDIN in Japan as well as development and commercialization in China and other key growth markets across Asia.
