First Patient Enrolled and Dosed in Novan’s SB206 Phase 3 Molluscum Program
- Phase 3 pivotal program commences and underway
- Investigative sites now activated and enrollment activities actioned
- Anticipated patient demand managed with a highly disciplined approach to trial execution
- Top line results targeted to be no later than early in the first quarter of 2020
The B-SIMPLE Phase 3 program consists of two multi-center, randomized, double-blind, vehicle-controlled studies, B-SIMPLE1 and B-SIMPLE2. Each study will enroll approximately 340 patients. The program will evaluate the efficacy and safety of SB206 12% QD (once daily) compared to vehicle (placebo) for the treatment of molluscum.
“Molluscum contagiosum is a terribly frustrating condition for affected children and their parents. Despite the self-limited nature of the skin infection, spontaneous resolution can take quite a while. Fears regarding potential viral transmission to others, secondary infection of lesions and scarring can create a sense of treatment urgency,” stated Dr.
Currently there are no
“Novan is committed to swiftly advancing SB206 in a high quality and disciplined manner. With success, our aim is to provide patients with a simple topical treatment for this contagious condition that can be administered in the home setting,” stated
About B-SIMPLE Phase 3 Program
The B-SIMPLE Phase 3 program consists of two multi-center, randomized, double-blind, vehicle-controlled studies, B-SIMPLE1 and B-SIMPLE2, to evaluate the efficacy and safety of SB206 12% QD for the treatment of molluscum. Each pivotal study will enroll approximately 340 patients aged 6 months and older, with a 2:1 (active:vehicle) randomization. Subjects or their caregivers will apply SB206 12% or Vehicle Gel once daily for a minimum of 4 weeks and up to 12 weeks to all treatable lesions (baseline and new). There will be visits at Screening/Baseline, Week 2, Week 4, Week 8, Week 12 and safety follow-up at Week 24. The primary endpoint of these studies is the proportion of patients with complete clearance of all treatable molluscum lesions at Week 12.
About Molluscum Contagiosum
Molluscum contagiosum is a common, contagious skin infection caused by the molluscipoxvirus, affecting approximately six 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 around 100 lesions. Due to the largely pediatric nature of the disease, parents are the caregivers for these children, in most cases, and tend to seek treatment. There are no
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, enrollment demand and progress of our Phase 3 program to evaluate SB206 for the treatment of molluscum. 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, potential for delays and that results of earlier research and preclinical or clinical trials may not be predictive of results, conclusions or interpretations of later research activities or additional trials; risks related to the regulatory approval process, which is lengthy, time-consuming and inherently unpredictable, including the risk that our product candidates may not be approved or that additional studies may be required for approval or other delays may occur and that we may not obtain funding sufficient to complete the regulatory or development process; our ability to obtain additional funding or enter into strategic relationships or other business development necessary for the further development of our product candidates; and other risks and uncertainties described in our annual report filed with the
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Director, Investor Relations, Communications & Business Development
Source: Novan, Inc.