Novan announces results from Phase 2 SB206 trial
Novan announced full top line results from the company's Phase 2 clinical trial to evaluate topical nitric oxide product candidate SB206 for the treatment of molluscum contagiosum, including results from the fourth cohort, SB206 12% once-daily. Results demonstrated a clear treatment effect on the complete clearance of all molluscum lesions at Week 12 for 12% once-daily SB206 gel, with signs of efficacy evident as early as Week 2. The safety and tolerability profiles for all treatment groups were favorable, with no serious adverse events reported. Preliminary top line results from the first three cohorts, 4%, 8% and 12% twice-daily, were announced in November. Novan conducted a 12-week, randomized, double-blind, vehicle-controlled, ascending dose Phase 2 trial to evaluate four treatment groups of 4%, 8% or 12% twice-daily or 12% once-daily, and vehicle as a treatment for molluscum. The primary endpoint was complete clearance of all molluscum lesions at Week 12. For the primary endpoint, 12% once-daily was the most effective dose with 42% and 38% complete clearance rates compared to 20% and 18% for vehicle, respectively. For the secondary endpoint of mean percent change from baseline molluscum lesion count at each visit, patients treated with 12% once-daily experienced 29%, 37%, 56% and 55% reductions in molluscum lesions at Week 2, 4, 8 and 12, respectively. The 12% once-daily treatment group had the lowest dropout rate out of all treatment groups, 9%, with 0 patients discontinuing treatment due to adverse event. With the full results from this Phase 2 trial now available, the company intends to request, by the end of December, an end-of-Phase 2 meeting with the FDA. This meeting would enable Novan and the FDA to agree on a Phase 3 development plan for molluscum with SB206 12% once-daily as the active treatment arm. 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 the first half of 2019 with top line results possible by the end of 2019 or early in 2020.