Nielsen BioSciences' CANDIN Achieves Primary Endpoint in First Phase 3 Trial for Common Warts Treatment
Key Insights
Nielsen BioSciences (search) announced positive Phase 3 trial results for CANDIN, showing complete resolution of injected warts without recurrence over 12 weeks in 325 patients.
The study represents the first successfully completed, randomized, placebo-controlled Phase 3 trial for common warts (search), an HPV-driven skin condition.
Secondary endpoints demonstrated CANDIN's systemic effect, with clearance of non-injected warts in over 50% of patients beyond the treated site.
Nielsen BioSciences (search) announced that its Phase 3 clinical trial of CANDIN (Purified Candida albicans Antigen (search)) successfully met its primary endpoint for treating common warts (search), marking a significant milestone as the first randomized, placebo-controlled Phase 3 study completed for this HPV-driven skin condition. The company expects to file for FDA approval in the second half of 2026.
Trial Design and Results
The multinational study analyzed 325 patients aged 12 years and older across the United States and Japan, comparing CANDIN injections to saline placebo. The trial achieved its primary endpoint of complete resolution of the injected wart without recurrence through 12 weeks post-injection.
Key secondary endpoints were also met, including the number of injections required to achieve clearance of the injected wart and clearance of all or greater than 50% of measured warts beyond the injected site. These results provide evidence of CANDIN's systemic immunotherapeutic effect, suggesting the treatment can clear warts beyond the injection site.
The study additionally assessed scarring and skin discoloration, addressing key concerns that patients and dermatologists have with traditional wart treatment methods.
Clinical Significance
"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 (search) who are in urgent need of new treatment options," said Robert Esch, PhD, co-author of the study and Board of Directors member at Nielsen BioSciences (search).
The topline results were presented at the Society of Investigative Dermatology Annual Conference in a late-breaking poster session, highlighting the clinical significance of these findings.
Regulatory Timeline and Partnership
Nielsen BioSciences (search) is currently completing analysis of the full Phase 3 dataset and Clinical Study Report. The company plans to submit for FDA approval in the second half of 2026, which could position CANDIN as the first approved therapeutic for HPV-driven skin infections (search).
The development strategy included partnering with Maruho Co. Ltd (search), a leading dermatology-focused pharmaceutical company headquartered in Japan. Maruho serves as the exclusive licensee for CANDIN commercialization in Japan and holds development and commercialization rights for China and other key Asian growth markets.
"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 (search).
About CANDIN
CANDIN is currently licensed in the United States as an FDA-approved skin test antigen for assessing cellular hypersensitivity to Candida albicans. The investigational immunotherapeutic therapy is not currently approved in the United States or Japan for treating common warts (search) or any other therapeutic indications beyond its diagnostic use.