Novan Reports Top-Line Efficacy Results from Phase 3 Trials of SB206 for Molluscum Contagiosum
- Company to hold conference call
Friday, January 3, 2020at 8:30 am Eastern Time
- Focus of call: top-line efficacy data and sensitivity analyses
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 FDAfeedback.
- 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
FDAand 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
The B-SIMPLE program consists of two multi-center, randomized, double-blind, vehicle-controlled pivotal trials of topical nitric oxide-releasing product candidate SB206 for the treatment of molluscum in 707 patients aged 6 months and older, with a 2:1 (active:vehicle) randomization.
Primary endpoint – proportion of patients with complete clearance of all treatable molluscum lesions at Week 12 (Intent-to-Treat or “ITT” population, where the analysis assumes that patients with Week 12 missing data are computed as treatment failures):
SB206 was near statistically significant for the primary endpoint in B-SIMPLE2, and was statistically significant in the secondary endpoint and several pre-specified sensitivity analysis, which were included within the statistical analysis plan:
|Primary endpoint – complete
|clearance at Week 12||Intent-to-Treat2 with Last
Observation Carried Forward3
missing data method
|Secondary endpoint – complete
clearance at Week 8
1. Per-protocol (“PP”) population: all patients in the ITT population who completed the 12-week treatment period and had no significant protocol deviations that impacted the analyses of efficacy endpoints.
2. Intent-to-Treat Population (“ITT”): consists of all subjects who are randomized.
3. Last Observation Carried Forward (“LOCF”) method for handling missing data: all patients randomized (ITT population) and where a patient missed their Week 12 visit but had reported complete clearance at their last collected lesion assessment, their last visit lesion count is included in the analysis as complete clearance at Week 12.
Following an assessment of the primary analysis and pre-specified sensitivity analyses,
Management, along with the Board of Directors, continues to explore both financial as well as strategic options in order to continue to progress SB206 for the molluscum indication. As disclosed in the latest 10-Q filing, as of
The Company, along with the Board of Directors, will provide a further business update in a timely manner and when appropriate.
Select members of the management team will attend the 7th Annual Dermatology Summit, taking place on
Conference Call & Webcast (with Slides)
|U.S. toll free:||+1 (844) 707-0661|
|International:||+1 (703) 318-2240|
A live webcast will be accessible from the Events page of the Company’s website at http://Events.Novan.com.
This press release contains forward-looking statements including, but not limited to, statements related to pharmaceutical development of nitric oxide-releasing product candidates and our intention to advance development of certain product candidates, including the timing of full results of our Phase 3 program to evaluate SB206 for the treatment of molluscum, the outcome of discussions with the
(Investors & Media)
Director, Investor Relations, Communications & Business Development
Source: Novan, Inc.