Novan Announces Presentation of Two Posters at the 2022 Winter Clinical Dermatology Conference

Rhea-AI Summary

Novan, Inc. (Nasdaq: NOVN) announced the presentation of data from its Phase 2 and Phase 3 studies on berdazimer 10.3% gel during the 2022 Winter Clinical Dermatology Conference in Hawaii. This gel is aimed at treating molluscum contagiosum, a viral skin condition impacting around 6 million Americans, primarily children. If approved, it would be the first FDA-sanctioned treatment for this condition. The data includes efficacy and safety results from the Phase 2 study and novel inflammation data from three Phase 3 studies, indicating potential advancements in treatment.

Positive

• Presentation of positive Phase 2 and Phase 3 clinical study results for berdazimer 10.3% gel.
• Berdazimer gel aims to address a significant unmet medical need for molluscum contagiosum treatment.
• Potential for FDA approval as the first topical treatment for molluscum contagiosum.

Negative

• None.

DURHAM, N.C., Jan. 14, 2022 (GLOBE NEWSWIRE) -- Novan, Inc. (“the Company” or “Novan”) (Nasdaq: NOVN), today announced that data from the Company’s completed Phase 2 and Phase 3 clinical studies of berdazimer 10.3% gel (previously referred to as SB206) for molluscum contagiosum will be presented at the 2022 Winter Clinical Dermatology Conference, being held January 14-19, 2022, in Koloa, Hawaii.

Berdazimer 10.3% gel, containing new chemical entity berdazimer (sodium), is in late-stage development and poised as a first-in-class topical controlled-nitric oxide releasing medication for the treatment of molluscum contagiosum, a highly contagious viral skin disease affecting an estimated 6 million people in the US, mostly children, if approved. There is currently no US Food & Drug Administration (FDA) approved medication indicated for the treatment of molluscum. If approved, the Company believes berdazimer 10.3% gel would offer those infected with molluscum a potential prescription therapeutic approach that could allow patients and/or caregivers to directly apply treatment gel to molluscum lesions.

The data presented at Winter Clinical features the efficacy and safety data from the Phase 2 study as well as Beginning of the End (BOTE) sign data collected from three Phase 3 studies. The latter represents a clinical sign of inflammation and imminent resolution of molluscum lesions that has never been prospectively studied in a molluscum clinical trial.

About the Poster Presentations:

Title: BOTE (Beginning Of The End) is a Clinical Sign of Molluscum Contagiosum Resolution Enhanced by SB206, an Investigational Nitric Oxide–Releasing Topical Medication
Authors: Tomoko Maeda-Chubachi, MD, PhD, MBA, Martina Cartwright, PhD, Elaine Siegfried, MD

Title: Results of Phase 2 Study Evaluating the Efficacy and Safety of SB206, Topical Berdazimer Sodium Gel, in Subjects with Molluscum Contagiosum
Authors: John Browning, MD, Adelaide Hebert, MD, Carolyn Enloe, MPH, Tomoko Maeda-Chubachi, MD, Martina Cartwright, PhD

Posters appear throughout the meeting within the Poster Gallery in the Grand Promenade of the Grand Hyatt Kauai.

For more information about the conference, visit: https://fallclinical.health/

About Novan

Novan, Inc. is a pre-commercial nitric oxide-based pharmaceutical company focused on dermatology and anti-infective therapies. We leverage our core synergies of science, capital, resources and patient needs to create value by bringing new nitric oxide-based medicines to market. Our goal is to create the world’s leader in nitric oxide-based science, technology, and clinical translation in support of delivering safe and efficacious therapies using our proprietary nitric oxide-based technology platform, NITRICIL™ to generate macromolecular New Chemical Entities (NCEs) to treat 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 10.3% gel (SB206) for molluscum contagiosum, and the potential benefits of berdazimer 10.3% gel, 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; any operational or other disruptions as a result of the COVID-19 pandemic; the Company’s ability to 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 its development, manufacturing and commercialization 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 Securities and Exchange Commission on Form 10-K for the twelve months ended December 31, 2020, 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 are the results of Novan's recent clinical studies on berdazimer 10.3% gel?

Novan presented positive results from Phase 2 and Phase 3 studies, showing efficacy and safety data at the 2022 Winter Clinical Dermatology Conference.

When and where were the clinical data for berdazimer presented?

The clinical data for berdazimer 10.3% gel were presented at the 2022 Winter Clinical Dermatology Conference held from January 14-19, 2022, in Koloa, Hawaii.

What condition does berdazimer 10.3% gel target?

Berdazimer 10.3% gel targets molluscum contagiosum, a viral skin disease affecting approximately 6 million people in the US.

What is the significance of the Phase 3 study data for berdazimer?

The Phase 3 study data includes new inflammation sign data, which is significant as it has not been prospectively studied in prior molluscum clinical trials.