Nielsen Biosciences Announces Enrollment of First Patient in Phase 3 Trial of CANDIN for the Treatment of Common Warts

Nielsen BioSciences, Inc. ("Nielsen"), a privately-held, San Diego-based biopharmaceutical company, today announced the first patient enrolled in CFW-3A ? a Phase 3, randomized, double-blind, placebo-controlled study of the safety and efficacy of CANDIN^® for the treatment of Verruca vulgaris (common warts) in adolescents and adults. The study is ongoing and will continue to enroll patients across sites in the U.S. and Japan, making this Nielsen's first clinical study with global reach. Nielsen is partnering with Maruho Co. Ltd. ("Maruho") in the clinical development program for CANDIN. Maruho is also planning to commercialize CANDIN in Japan.

"The first patient treated with CANDIN represents a major milestone for the company, and for patients affected by common warts around the world," said David P. Burney, PhD, MBA, President and Chief Operating Officer at Nielsen BioSciences. "We are proud of this new phase in our continuous effort to develop this new therapy and make it available to a patient population with high unmet need."

Verruca vulgaris are benign lesions caused by infection of the skin with the human papillomavirus (HPV). They are raised lesions on the skin, commonly on the fingers, palms, knees, and soles of the feet. Since warts are caused by a viral infection, skin symptoms can be widespread and refractory. Common warts are estimated to affect approximately 10 percent of the global population.¹ There are currently no FDA-approved prescription treatments.

"We are in dire need of new therapies for wart treatment. I am excited about this trial and the potential to provide patients with an alternative to standard wart removal via acid, surgery, cryotherapy and other methods that can damage skin," said Sandra Johnson, MD, FAAD, Dermatologist from Fort Smith Arkansas and one of the principal investigators of this clinical trial.

About the Study

The study is 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. The goal of the clinical trial is to compare outcome in healthy subjects 12 years of age and older with at least 3, but no more than 20, common warts (Verruca vulgaris) following treatment with CANDIN or placebo. For more information, please see the study details at ClinicalTrials.gov.

About Nielsen BioSciences

Nielsen BioSciences, Inc. is a privately-held, San Diego-based biopharmaceutical company focused on developing and commercializing biological products with wide-ranging applications in cell-mediated immune responses. For more information, please visit https://nielsenbio.com/about-us/.

About CANDIN

CANDIN (Candida albicans Skin Test Antigen for Cellular Immunity) ("CANDIN") is currently marketed in the United States for its U.S. Food and Drug Administration-approved use as a skin test antigen for the assessment of cellular hypersensitivity to Candida albicans. CANDIN is not currently approved in the United States or Japan for the treatment of Verruca vulgaris or any other indications. In the United States, Nielsen previously completed a Phase II clinical trial investigating CANDIN in the treatment of human papillomavirus (HPV) conditions, including Verruca vulgaris.

About Maruho

Maruho Co., Ltd. has its headquarters in Osaka and leads Japan in research and development, manufacturing and commercialization of dermatological products. Founded in 1915, Maruho has 1,566 employees (as of the end of September 2023), and net sales were approximately 85.71 billion yen in its fiscal year ending September 30, 2023. With the mission "More smiles, brighter life for you.", Maruho aims to help realize a society where everyone can live with a smile. For more information, please visit https://www.maruho.co.jp/english/

¹ Wart ? StatPearls ? NCBI Bookshelf (nih.gov), Accessed on May 5, 2023.