Novan Announces Late-Breaking Abstract Accepted for Presentation at American Academy of Dermatology’s (AAD) 2022 Annual Meeting

Rhea-AI Summary

Novan (Nasdaq: NOVN) announced that its pivotal Phase 3 study data of berdazimer gel 10.3% for molluscum contagiosum will be presented orally at the American Academy of Dermatology’s 2022 Annual Meeting on March 26, 2022. This presentation, led by Dr. John Browning, highlights the compelling data from the B-SIMPLE4 study. The company aims to provide a prescription treatment option for this highly contagious viral skin condition, which currently lacks FDA-approved treatments. If approved, berdazimer gel could offer a safe and effective solution for affected patients.

Positive

• Data from the pivotal Phase 3 study of berdazimer gel was selected for presentation at a notable dermatology conference, indicating strong clinical interest.
• The gel aims to address a significant unmet medical need in treating molluscum contagiosum, which currently has no FDA-approved treatments.

Negative

• The FDA's approval process could involve uncertainties and delays, potentially impacting market access for berdazimer gel.

DURHAM, N.C., March 24, 2022 (GLOBE NEWSWIRE) -- Novan, Inc. (“the Company” or “Novan”) (Nasdaq: NOVN), today announced that data from its pivotal Phase 3 study of berdazimer gel 10.3% (SB206) for the treatment of molluscum contagiosum was selected for an oral presentation at a late-breaker session at the American Academy of Dermatology’s (AAD) 2022 Annual Meeting.

Details of the abstract presentation are as follows:

Title:	Berdazimer 10.3% Gel (SB206): A Novel, Topical Nitric Oxide Releasing Medication: Results from a Pivotal Phase 3 Study in Patients (Children and Adults) with Molluscum Contagiosum
Session:	Clinical Studies/Pediatric
Date & Time:	March 26, 2022, at 10:20am ET
Location:	Rm. 253A

The presentation will be given by Dr. John Browning M.D., F.A.A.D, F.A.A.P., MBA, Adjunct Associate Professor of Pediatrics and Dermatology at UT Health San Antonio and Baylor College of Medicine, and a Principal Investigator in the B-SIMPLE4 study.

“We are pleased to present the compelling data from our Phase 3 study, BSIMPLE-4, at this prestigious dermatology event. Molluscum is a highly contagious skin virus affecting many children that currently has no FDA-approved prescription drug treatment options. Based on the robust clinical data demonstrated to date, if approved, we believe our topical berdazimer gel 10.3% could offer patients and caregivers a safe and effective self-applied medication to treat molluscum,” commented Tomoko Maeda-Chubachi, M.D., Ph.D., MBA, Chief Medical Officer of Novan.

About Novan

Novan, Inc. is a specialty dermatology company focused on researching, developing and marketing innovative therapeutic products for skin diseases. Through our acquisition of EPI Health, we sell products for acne, rosacea, dermatosis, and psoriasis. Our goal is to deliver safe and efficacious therapies where there are unmet medical needs. We are developing SB206 (berdazimer gel 10.3%) as a topical prescription gel for the treatment of viral skin infections, with a current focus on molluscum contagiosum. We have a pipeline of product candidates using our proprietary nitric oxide-based technology platform, NITRICIL™, to generate new treatments for multiple indications.

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,” “target,” “anticipate,” “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, such as berdazimer gel 10.3% (SB206) for molluscum contagiosum, and the potential benefits of berdazimer gel 10.3%, if approved. 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 related to the regulatory approval process, which is lengthy, time-consuming and inherently unpredictable, including the risk that the FDA will not agree with the Company’s approach to a potential NDA submission, that the Company’s product candidates may not be approved or that additional studies may be required for approval or other delays may occur, that the Company may not have sufficient quantities of drug substance and/or drug product to support regulatory submissions and that the Company may not obtain funding sufficient to complete the regulatory or development process; the Company’s limited experience as a company in obtaining regulatory approvals and commercializing pharmaceutical products 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; the Company’s ability to maximize the benefit of the EPI Health acquisition and obtain additional funding or enter into strategic or other business relationships necessary or useful for the further development or commercialization of the Company’s product candidates; the Company’s reliance on arrangements with third parties to support its operations 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 Securities and Exchange Commission on Form 10-K for the twelve months ended December 31, 2021, and in the Company’s subsequent filings with the Securities and Exchange Commission. Such 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 berdazimer gel 10.3% and what condition does it treat?

Berdazimer gel 10.3% is a topical medication aimed at treating molluscum contagiosum, a contagious viral skin infection.

When will the data from the Phase 3 study of berdazimer gel be presented?

The data will be presented on March 26, 2022, at the American Academy of Dermatology’s Annual Meeting.

Who is presenting the study results at the AAD meeting?

Dr. John Browning will present the study results during the session.

What does the Phase 3 study data suggest about berdazimer gel?

The study data suggests that berdazimer gel could offer a safe and effective treatment option for patients with molluscum contagiosum.

What are the risks associated with Novan's regulatory approval process?

There are risks related to the FDA approval process, including potential delays and the need for additional studies.