Press ReleaseView printer-friendly version << Back
Novan Phase 2 Molluscum Contagiosum Trial Achieves Statistical Significance in Preliminary Top Line Results
- Higher rates of complete clearance of all molluscum lesions at Week 12 for the two highest doses, SB206 8% and 12% twice-daily, more than double the rate observed in the vehicle group
- Clear treatment effect observed as early as Week 4 in the percent reduction of molluscum lesions
- Attractive safety and tolerability profile, a critical and highly appealing feature for a predominantly childhood disease
- SB206 as a topical, at-home, caregiver-applied therapy with a rapid treatment benefit, if approved, would satisfy an important patient-care need for the treatment of molluscum
- End-of-Phase 2 meeting to be requested in 4Q 2018 and Phase 3 program expected to begin in 1H 2019
- Number of patients: 256 total; 192 in Cohorts 1 through 3; 64 in Cohort 4.
- Inclusion criteria: Ages 2 years and older, with 3 to 70 molluscum lesions.
- Primary endpoint: Complete clearance of all molluscum lesions at Week 12.
- 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.
“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
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
“It is important to remember that this disease is largely present in children and the average age in our clinical trial was seven years,” commented
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
This press release contains forward-looking statements including, but not limited to, statements related to pharmaceutical development of nitric oxide-releasing product candidates, our intention to advance the development of SB206 for the treatment of molluscum, which is subject to our ability to obtain additional financing or enter into strategic relationships to enable such development, and the future prospects of our business and our product candidates. Forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from our expectations, including, but not limited to: risks and uncertainties in the clinical development process, including, among others, length, expense, ability to enroll patients, reliance on third parties, and that results of earlier research and preclinical or clinical trials may not be predictive of results, conclusions or interpretations of later research or trials; risks that data from the fourth cohort impact our assessment of SB206 for the treatment of molluscum; risks related to the regulatory approval process, which is lengthy, time-consuming and inherently unpredictable; our ability to obtain substantial additional funding for the further advancement and development of our product candidates; our ability to identify and enter into strategic relationships for the further development and potential commercialization of our product candidates; and other risks and uncertainties described in our annual report filed with the
Director, Investor Relations, Capital Sourcing & Relationships
Director, Corporate Communications and Administration