Novan�s phase III Molluscum pivotal program completes enrollment of B-SIMPLE trials for SB 206

Novan, Inc. announced that the Company has recently completed patient recruitment in the Company’s ongoing “B-SIMPLE” (Berdazimer Sodium In Molluscum Patients with Lesions) Phase III pivotal trials with SB 206 for the treatment of molluscum contagiosum. The trials enrolled approximately 680 patients with 3 to 70 molluscum lesions at Baseline.

The primary efficacy endpoint of the trials is complete clearance of all treatable molluscum lesions at Week 12, and follow-up will include a Week 24 safety assessment.The SB 206 results from Phase II, previously announced in December 2018, demonstrated a clear treatment effect on the complete clearance of all molluscum lesions at Week 12 for 12% once-daily SB 206 gel. There were signs of efficacy as early as Week 2, and the Phase II trial showed a favorable safety profile. For the primary endpoint, 12% once-daily was the most effective dose with 38% (ITT, p<0.05) complete clearance rates compared to 18% for vehicle.

About B-SIMPLE Phase III Program : The B-SIMPLE Phase III program consists of two multi-center, randomized, double-blind, vehicle-controlled studies, B-SIMPLE1 and B-SIMPLE2, to evaluate the efficacy and safety of SB 206 12% once daily for the treatment of molluscum. Each pivotal study will enroll approximately 340 patients aged 6 months and older, with a 2:1 (active:vehicle) randomization. Subjects or their caregivers will apply SB 206 12% or Vehicle Gel once daily for a minimum of 4 weeks and up to 12 weeks to all treatable lesions (baseline and new). There will be visits at Screening/Baseline, Week 2, Week 4, Week 8, Week 12 and safety follow-up at Week 24. The primary endpoint of these studies is the proportion of patients with complete clearance of all treatable molluscum lesions at Week 12.

Molluscum contagiosum is a common, contagious skin infection affecting 6 million people in the U.S. annually, with the greatest incidence in children aged one to 14 years. Infected children typically present with 10 to 30 painless, yet unsightly lesions, and, in severe cases, they can have up to 100 lesions. Due to the largely pediatric nature of the disease, in most cases, parents are the caregivers for these children and tend to seek treatment. There are currently no FDA approved therapies for the treatment of molluscum.