Top line results from Novan’s Phase 2 clinical trial to evaluate topical nitric oxide product candidate SB206 for the treatment of molluscum contagiosum are promising. Data for three full cohorts of four show that 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. Results for Cohort 4, SB206 12% once-daily, are targeted to be announced in December.
Novan conducted a 12-week, randomized, double-blind, vehicle-controlled, ascending dose Phase 2 trial to evaluate four treatment groups of 4%, 8% and 12% twice-daily and 12% once-daily, and vehicle as a treatment for molluscum. A total of 256 subjects, ages two and older, were enrolled in the trial. The primary endpoint was complete clearance of all molluscum lesions at Week 12.
The totality of the primary and secondary endpoint analyses received to date indicates a clear dose response, in both the Modified Intent-to-Treat (mITT) and Intent-to-Treat (ITT) populations.
Forthe primary endpoint, 8% twice-daily was the most effective dose, with 41% complete clearance compared to 17% for vehicle (mITT, p<0.05). There was no further treatment benefit from the additional nitric oxide delivered by 12% twice-daily, with complete clearance rates of 35%. At Week 12, 0% of patients reported severe burning, stinging and itching and less than 3% of patients reported moderate levels of these.
“The trial was designed to evaluate the efficacy, safety and tolerability of SB206 across a range of doses and identify a dose to carry forward in clinical development,” stated Paula Brown Stafford, Novan’s Chief Development Officer. “While the trial was not powered for formal statistical comparisons, we are encouraged by the higher rates of complete clearance of all molluscum lesions at Week 12, with clearance as early as Week 4, in the 8% and 12% twice-daily treatment groups. In addition, our secondary endpoints received to date are supportive of and consistent in direction with the primary endpoint of complete clearance. We look forward to receiving the results of Cohort 4 and discussing these data with the FDA as soon as possible.”
Based on the data generated in this Phase 2 trial, the Science and Technology Committee of Novan’s Board of Directors has recommended that the Company proceed expeditiously, and by the end of the fourth quarter, 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 the first half of 2019 with top line results possible by the end of 2019 or early in 2020.