Novan to Present Clinical Data at Annual Meeting of the Society for Investigative Dermatology

Rhea-AI Summary

Novan, Inc. (NASDAQ: NOVN) announced data from its Phase 3 trials for SB206, a topical treatment for molluscum contagiosum, will be presented at the Society for Investigative Dermatology's virtual meeting from May 3-8, 2021. The integrated data from trials B-SIMPLE1 and B-SIMPLE2 will have an ePoster presentation on May 5, 2021. Molluscum contagiosum affects approximately six million people in the U.S. annually, primarily children, with no FDA-approved treatments available. This presentation aims to highlight the significant unmet needs in molluscum treatment.

Positive

• Presentation of positive Phase 3 trial data for SB206 at a major dermatology conference.
• The presentation seeks to address significant unmet needs for molluscum contagiosum, a common skin infection.

Negative

• No FDA-approved therapies for molluscum contagiosum exist, indicating potential market limitations.
• More than half of molluscum patients are untreated, suggesting challenges in market penetration.

MORRISVILLE, N.C., April 22, 2021 (GLOBE NEWSWIRE) -- Novan, Inc. (“the Company” or “Novan”) (Nasdaq: NOVN), today announced that data from the Company’s previously completed Phase 3 trials of SB206 for molluscum contagiosum (B-SIMPLE1, B-SIMPLE2) will be presented at the Virtual Annual Meeting of the Society for Investigative Dermatology (SID), being held May 3-8, 2021.

Integrated data from the B-SIMPLE1 and B-SIMPLE2 multicenter, randomized, double-blind, vehicle-controlled clinical trials evaluating the Company’s topical nitric oxide–releasing SB206 gel will be presented in an ePoster presentation on May 5, 2021 from 2:30 – 4:00 PM ET.

About the ePoster Presentation

Title: BOTE (Beginning Of The End) inflammation can be enhanced with SB206, a nitric oxide‐releasing topical medication for molluscum contagiosum
Abstract and Poster Number: 400
Authors: Tomoko Maeda-Chubachi, MD, PhD, MBA, David Hebert, PhD, Elaine Siegfried, MD, Elizabeth Messersmith, PhD
Interactive Poster/Exhibitor Session I: Patient Targeted Research
Date and Time: May 5, 2021 from 2:30 – 4:00 PM ET
ePoster Talks: Available on-demand from May 3-May 31, 2021

For more information about the conference, please visit www.sidannualmeeting.org.

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 U.S. Food and Drug Administration (“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 or in the announced presentation 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 the potential therapeutic value of the Company’s NITRICIL™ platform technology, the Company’s pharmaceutical development of nitric oxide-releasing product candidates and the Company’s intention to advance development of certain product candidates. Forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from the Company’s expectations, including, but not limited to, risks and uncertainties in the Company’s ongoing or future product development activities and preclinical studies, which may not prove successful in demonstrating proof-of concept, or may show adverse toxicological findings, and even if successful may not necessarily predict that subsequent clinical trials will show the requisite safety and efficacy of the Company’s product candidates; any operational or other disruptions as a result of the COVID-19 pandemic, including any delays or disruptions to the conduct of the B-SIMPLE4 study; the Company’s ability to enter into arrangements with third parties to support its development efforts on terms that are acceptable to the Company or at all; risks and uncertainties in the clinical development process, including, among others, length, expense, ability to enroll patients, 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 the Company’s product candidates may not be approved or that additional studies may be required for approval or other delays may occur and that the Company may not obtain funding sufficient to complete the regulatory or development process; the Company’s ability to obtain additional funding or enter into strategic or other business relationships necessary or useful for the further development of the Company’s product candidates; the risk that disruptions at the U.S. Food and Drug Administration 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 the Company’s regulatory submissions, all of which could have a material adverse effect on the Company’s business; risks related to the manufacture of raw 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 U.S. Food and Drug Administration or comparable regulatory authorities; the Company’s reliance on arrangements with third parties to support its operations and development efforts and the risk that such parties will not successfully carry out their contractual duties or meet expected deadlines; and other risks and uncertainties described in the Company’s annual report filed with the SEC on Form 10-K for the twelve months ended December 31, 2020, and in the Company’s subsequent filings with the SEC. Such forward-looking statements speak only as of the date of this press release or the announced presentation, as applicable, 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 are the main results being presented for NOVN's SB206?

The results from Phase 3 trials B-SIMPLE1 and B-SIMPLE2 for SB206 will be showcased, focusing on its efficacy against molluscum contagiosum.

When will the SB206 data presentation occur?

The SB206 data will be presented at the Society for Investigative Dermatology's virtual meeting on May 5, 2021.

What is molluscum contagiosum and why is it significant for NOVN?

Molluscum contagiosum is a common skin infection affecting millions, particularly children. NOVN's SB206 aims to fulfill an unmet medical need in this area.

How does SB206 aim to improve treatment for molluscum contagiosum?

SB206 is a topical gel that releases nitric oxide and is designed for caregiver-applied therapy at home, potentially offering a non-invasive treatment option.

What are the implications of the Phase 3 trial results for NOVN's future?

Positive trial results could lead to regulatory approval and market introduction of SB206, addressing a significant treatment gap in molluscum contagiosum.