Novan Announces Positive Preliminary Results On Molluscum Contagiosum

(RTTNews) - Novan Inc. (NOVN) 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. 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.

Primary statistical analysis population: Prespecified as Modified Intent-to-Treat (mITT), consisting of all patients who were randomized and completed the study treatment. A sensitivity analysis of the primary endpoint was repeated using the ITT population.

The totality of the primary and secondary endpoint analyses received to date indicates a clear dose response, in both the mITT and ITT populations. The preliminary top line results include: The 4% twice-daily dose showed a modest biological signal across all endpoints. In the 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.

Full trial results including data from the fourth cohort, 12% once-daily, 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. 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.

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.

The 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.