Novan announced top-line efficacy results from its Phase 3 B-SIMPLE program with SB206 for the treatment of molluscum contagiosum. The B-SIMPLE program consists of two multi-center, randomized, double-blind, vehicle-controlled pivotal trials (B-SIMPLE1 and B-SIMPLE2). The trials evaluated topical nitric oxide-releasing product candidate SB206 in 707 patients aged 6 months and older, with a 2:1 (active:vehicle) randomization.
The primary endpoint was the proportion of patients with complete clearance of all treatable molluscum lesions at Week 12. Statistical significance was not achieved for the primary endpoint in either trial. The two trials are ongoing, awaiting 24-week safety data, thus the top-line results are for efficacy data only. B-SIMPLE2 was statistically significant for multiple pre-specified sensitivity analyses. Full efficacy and safety data from both trials, including the prospectively planned safety evaluation ongoing through Week 24, are targeted to be available by March 2020.
The company intends to utilize B-SIMPLE2 as one of the confirmatory trials for New Drug Application (NDA) submission, subject to discussions with the U.S. FDA. The company intends to su...
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