Novan, Inc. (“the Company” or “Novan”) (NASDAQ:NOVN) today announced top-line efficacy results from its Phase 3 B-SIMPLE program with SB206 for the treatment of molluscum contagiosum (“molluscum”). Statistical significance was not achieved for the primary endpoint in either B-SIMPLE1 or B-SIMPLE2, however multiple sensitivity analyses are supportive and consistent across both studies and support a potential path forward for the asset. The two trials are ongoing, awaiting 24-week safety data, thus the top-line results are for efficacy data only.
Summary of Top-Line Efficacy Data and SB206 Program:
- SB206 did not achieve statistically significant results for the primary endpoint.
- B-SIMPLE2 was statistically significant for multiple pre-specified sensitivity analyses.
- Similar analyses with B-SIMPLE1 demonstrated results are reasonably consistent and supportive of B-SIMPLE2.
- Company intends to utilize B-SIMPLE2 as one of the confirmatory trials for New Drug Application (“NDA”) submission, subject to discussions with the U.S. Food and Drug Administration (“FDA”).
- Company intends to support and confirm B-SIMPLE2 with an additional confirmatory Phase 3 trial targeted to commence in April 2020, subject to additional funding and FDA feedback.
- Company’s timeline for NDA submission remains consistent and targets potential NDA submission in the second quarter of 2021, depending on outcome of discussions with FDA and confirmatory results in the additional trial.
- Full efficacy and safety data from both trials, including the prospectively planned safety evaluation ongoing through Week 24, targeted to be available by March 2020.