Novan Phase 2 molluscum contagiosum trial achieves statistical significance
Novan announced 'positive' preliminary top line results for three full cohorts of four from the company's Phase 2 clinical trial to evaluate topical nitric oxide product candidate SB206 for the treatment of molluscum contagiosum. SB206 gel demonstrated a clear treatment effect on the complete clearance of all molluscum lesions at Week 12, with signs of efficacy evident as early as Week 4 for the two highest doses, 8% and 12% twice-daily. The safety and tolerability profiles were favorable overall with no serious adverse events reported. The totality of the primary and secondary endpoint analyses received to date indicates a clear dose response, in both the mITT and ITT populations. Full trial results are targeted to be announced in December. The purpose of this cohort is to evaluate the potential for a once-daily treatment option that would be attractive from a commercial perspective. 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. Based on the data generated in this Phase 2 trial, Novan's Science and Technology Committee has recommended that the company proceed expeditiously, and by the end of Q4, with a request to the FDA for an end-of-Phase 2 meeting. This meeting would enable Novan and the FDA to agree on a Phase 3 development plan for molluscum. Following a successful end-of-Phase 2 meeting with the FDA, the company plans to initiate a Phase 3 program of SB206 for molluscum in 1H19 with top line results possible by the end of 2019 or early in 2020.