Novan completes enrollment in pivotal Phase 3 molluscum contagiosum trial
Novan (NASDAQ:NOVN) has completed patient enrollment in its Phase 3 pivotal trial of SB206, a topical antiviral gel, for the treatment of molluscum contagiosum.
Molluscum contagiosum is a viral skin infection that primarily affects children aged one-to-14 years, and currently has no FDA-approved therapies.
The trial enrolled some 680 patients, each with three-to-70 molluscum lesions, and has a primary efficacy endpoint of complete clearance of all lesions at week 12.
“The pace by we which we fully enrolled these pivotal studies demonstrates the underlying demand and unmet medical need that exists for molluscum patients and their caregivers,” Elizabeth Messersmith, Novan’s senior VP and chief development officer, said in a statement.
Novan expects to report topline results from the trial in the first quarter of 2020.