Novan Initiates B-SIMPLE4 Pivotal Phase 3 Study of SB206 for Treatment of Molluscum

MORRISVILLE, N.C. , Aug. 31, 2020 (GLOBE NEWSWIRE) -- Novan Inc. ("the Company" or "Novan") (Nasdaq: NOVN), today announced the initiation of the B-SIMPLE4 pivotal Phase 3 clinical study of SB206, a topical antiviral gel, for the treatment of molluscum contagiosum (“molluscum”). Clinical sites are now open for patient enrollment.

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.

“Molluscum affects millions of people each year, a large percentage of those patients being children under the age of ten. SB206 represents, what I believe to be, an incredible opportunity to provide patients and caregivers an alternative treatment to the options currently available, including off-label prescriptions, procedures, and over-the-counter treatments with no clinical data that would support a molluscum indication and therefore have no proven clinical efficacy and an unknown safety profile. I believe SB206 has potential in addressing a significant unmet need in the treatment landscape of molluscum and if approved, would provide patients with a treatment benefit,” stated John Browning, M.D., F.A.A.D, F.A.A.P., MBA, Assistant Professor of Pediatrics and Dermatology and the Chief of Staff of Pediatric Dermatology at Texas Dermatology and Laser Specialists, and a Principal Investigator in the B-SIMPLE 4 clinical study.

B-SIMPLE4 is a multi-center, double-blind, randomized, vehicle-controlled study expected to enroll approximately 750 patients (1:1 randomization), across 45 clinical sites, who will be treated for 12 weeks with a follow-up visit at Week 24. The primary endpoint for the study is 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 missing data at Week 12 are assessed as treatment failures).

Paula Brown Stafford, Chairman, President and Chief Executive Officer of Novan commented, “We are pleased to initiate this study and are grateful for the dedication of our team who continue to navigate the commencement of a clinical trial in these unprecedented times with the COVID-19 pandemic. We worked diligently to partner with clinical sites that are actively seeing patients and are optimistic that we will reach our target to complete enrollment in the first quarter of 2021.”

Topline results from the B-SIMPLE4 trial are anticipated late in the second quarter of 2021, subject to the targeted timing for completing enrollment and trial execution plan which have been and may be further impacted by the COVID-19 pandemic.

Based on guidance the Company received during its Type C meeting with the U.S. Food and Drug Administration (“FDA”) and subsequently contained within the meeting minutes, Novan is conducting B-SIMPLE4 a pivotal Phase 3 trial, which if successful, could be supported by the previously completed B-SIMPLE2 trial in a future New Drug Application (“NDA”). There are currently no FDA-approved therapies for the treatment of molluscum. Treatment choices for patients include in-office and often painful, physician-administered scraping, freezing, burning and blistering treatments. The only other choices, which lack proven clinical efficacy and unknown safety profiles, are off-label prescriptions and over-the-counter treatments. The Company believes that 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.

About Molluscum

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 FDA approved therapies for molluscum, and, upon seeking treatment, caregivers are faced with potentially painful in-office, dermatologist-administered physical procedures or cantharidin, or recommended off-label prescriptions and over-the-counter products. More than half of the patients diagnosed with molluscum are untreated and over 30% of those treated receive an off-label prescription with no molluscum indication or proven clinical efficacy. The average time to resolution is 13 months, however, some children experience lesions that may not resolve in 24 months. Further dissemination of this highly-contagious disease is common, and transmission to other children living in the household is reported to be 41%. There is a significant unmet need in the molluscum treatment landscape.

About Novan

Novan, Inc. is a clinical development-stage biotechnology company focused on leveraging nitric oxide’s naturally occurring anti-microbial and immunomodulatory mechanisms of action to treat a range of diseases with significant unmet needs. We believe that our ability to deploy nitric oxide in a solid form, on demand and in localized formulations allows us the potential to improve patient outcomes in a variety of dermatology, women’s health and gastrointestinal diseases.

Forward-Looking Statements

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 and the timing of anticipated top-line results. 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 or other impacts, whether as a result of the COVID-19 pandemic or other factors, 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 or other business relationships necessary or useful for the further development of our product candidates; the risk that disruptions at the FDA or other agencies could cause such agencies to cancel or postpone meetings or otherwise impact the ability of such agencies to provide regulatory guidance or feedback or timely review and process our regulatory submissions, all of which could have a material adverse effect on our business; risks related to the manufacture of clinical trial materials; any operational or other disruptions as a result of the COVID-19 pandemic, including any delays or disruptions to the enrollment in and conduct of the B-SIMPLE4 Phase 3 trial; and other risks and uncertainties described in our annual report filed with the SEC on Form 10-K for the twelve months ended December 31, 2019, as amended, and in our subsequent filings with the SEC. These forward-looking statements speak only as of the date of this press release, and Novan disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances after the date of such statements, except as may be required by law.

INVESTOR AND MEDIA CONTACT:

Jenene Thomas
JTC Team, LLC
833-475-8247
NOVN@jtcir.com

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