Novan Exceeds 60% Enrollment in B-SIMPLE4 Pivotal Phase 3 Study of SB206 for Treatment of Molluscum

Rhea-AI Summary

Novan, Inc. (Nasdaq: NOVN) has announced the enrollment of 525 patients in its B-SIMPLE4 pivotal Phase 3 clinical study of SB206, a topical gel for treating molluscum contagiosum, with a target of 850 enrollees. The study aims to determine the gel's effectiveness, with topline results expected in Q2 2021. Molluscum contagiosum affects approximately six million people in the U.S. annually, primarily children. This trial is significant as there are currently no FDA-approved treatments available for molluscum, highlighting a critical unmet medical need.

Positive

• 60% patient enrollment achieved amidst COVID-19 challenges.
• Topical SB206 addresses a significant unmet need with no FDA-approved treatments available.
• Topline results are anticipated in Q2 2021, potentially leading to new treatment options.

Negative

• Completion of enrollment may be impacted by ongoing COVID-19 pandemic.
• Delays in regulatory approval processes could hinder product availability.

– Completion of patient enrollment targeted for Q1 2021 with readout of topline results targeted for Q2 2021 –

– SB206, if approved, has the potential to meet an important need for the treatment of molluscum, an area with no current FDA-approved treatment –

MORRISVILLE, N.C., Dec. 15, 2020 (GLOBE NEWSWIRE) -- Novan, Inc. (“the Company” or “Novan”) (Nasdaq: NOVN), today announced it has enrolled 525 patients of the approximately 850 patients expected to enroll in the B-SIMPLE4 pivotal Phase 3 clinical study of SB206, a topical antiviral gel, for the treatment of molluscum contagiosum (“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.

B-SIMPLE4 is a multi-center, double-blind, randomized, vehicle-controlled study expected to enroll approximately 850 patients (1:1 randomization), across approximately 50 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).

“Achieving 60% enrollment amidst the COVID-19 pandemic is a noteworthy accomplishment for our B-SIMPLE4 pivotal program and highlights the unmet need that exists for patients. We believe that SB206 has the potential to offer a solution to molluscum patients and we are encouraged by the overall enthusiasm we have seen for this study. I would like to take this opportunity to sincerely thank all the investigators and their staff, as well as the molluscum patients for their ongoing support and participation in the study,” commented Paula Brown Stafford, President and Chief Executive Officer of Novan.

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

There are currently no FDA-approved therapies for the treatment of molluscum. 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.

For more information about the B-SIMPLE4 trial, please visit clinicaltrials.gov and reference identifier: NCT04535531.

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 its proprietary nitric oxide (NO) based technology platform, NITRICIL™ to generate macromolecular New Chemical Entities (NCEs) to treat multiple indications in dermatology, men’s and women’s health, infectious diseases and gastroenterology conditions with significant unmet needs. The Company’s lead product candidate, SB206, a topical antiviral gel, for the treatment of molluscum contagiosum, is currently being evaluated in the B-SIMPLE4 pivotal Phase 3 clinical study. The Company believes that SB206 as a topical, at-home, caregiver-applied therapy with a rapid treatment benefit, if approved, would address an important patient-care need for the treatment of molluscum.

Forward-Looking Statements

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “believe,” “expect,” “may,” “plan,” “potential,” “will,” and similar expressions, and are based on the Company’s current beliefs and expectations. These forward-looking statements include, but are not limited to, statements related to potential therapeutic value of the Company’s NITRICIL™ platform technology, 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 topline 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, including the Company’s active pharmaceutical ingredient, and drug product components utilized in clinical trial materials, including failure to transfer technology and processes to third parties effectively or failure of those third parties to obtain approval of and maintain compliance with the FDA or comparable regulatory authorities; 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 

FAQ

What is the purpose of Novan's B-SIMPLE4 clinical study for SB206?

The B-SIMPLE4 clinical study aims to evaluate the efficacy of SB206 as a treatment for molluscum contagiosum.

How many patients are involved in the B-SIMPLE4 clinical trial?

The trial aims to enroll approximately 850 patients, with 525 already enrolled as of the latest update.

When are the topline results from the B-SIMPLE4 trial expected?

Topline results from the B-SIMPLE4 trial are anticipated to be available in the second quarter of 2021.

What is molluscum contagiosum and its current treatment landscape?

Molluscum contagiosum is a contagious skin infection affecting around six million people annually in the U.S., with no FDA-approved treatments currently available.

What are the potential implications of SB206's approval for the market?

If approved, SB206 could fulfill a significant treatment gap for molluscum contagiosum, providing a much-needed at-home therapy for affected patients.