Novan to Present Berdazimer Gel, 10.3% (SB206) Clinical Data at Annual Meeting of the Society for Investigative Dermatology

Rhea-AI Summary

Novan announced progress on its berdazimer gel, 10.3%, for treating molluscum contagiosum, based on the B-SIMPLE4 Phase 3 clinical study. This gel can potentially shorten the infection's duration and enhance clearance chances, addressing a significant unmet need as there are no FDA-approved therapies for molluscum. Novan aims to submit a New Drug Application (NDA) by the end of 2022, following positive topline results showing a statistically significant rate of complete lesion clearance. If approved, this could provide an effective treatment option for the 6 million people affected in the U.S. annually.

Positive

• Positive topline results from B-SIMPLE4 Phase 3 study showed a statistically significant primary efficacy endpoint (p-value <0.0001) for complete clearance of lesions.
• Berdazimer gel, 10.3%, was found to be well tolerated, with no treatment-related serious adverse events reported.
• There is currently no FDA-approved treatment for molluscum, indicating a potential market opportunity for berdazimer gel if approved.

Negative

• Approval of berdazimer gel is still pending, which introduces uncertainty regarding its future market availability.
• The regulatory approval process can be lengthy and unpredictable, posing risks to the timeline for NDA submission and potential market entry.

– Based on clinical data from previously completed B-SIMPLE4 pivotal Phase 3 clinical study, berdazimer gel, 10.3% (SB206) can shorten the duration of molluscum infection and increase the chance of clearance by enhancing inflammation of molluscum –

– Currently no FDA-approved prescription therapies for the treatment of molluscum –

– Novan advancing berdazimer gel, 10.3% toward New Drug Application (NDA) submission for molluscum contagiosum, targeted before end of 2022

DURHAM, N.C., May 19, 2022 (GLOBE NEWSWIRE) -- Novan, Inc. (“the Company” or “Novan”) (Nasdaq: NOVN), today announced it will present Beginning of The End (BOTE) clinical data from its previously completed Phase 3 trial of berdazimer gel, 10.3% for molluscum contagiosum (“molluscum”), B-SIMPLE4, at the Annual Meeting of the Society for Investigative Dermatology (SID) being held May 18-21, 2022 in Portland, Oregon.

Berdazimer gel, 10.3%, containing the new chemical entity berdazimer (sodium), is in late-stage development and poised as a potential first-in-class topical controlled-nitric oxide releasing medication for the treatment of molluscum, a highly contagious viral skin disease affecting an estimated 6 million people in the US, mostly children, if approved.

About the Poster Presentation:

Abstract: #294
Title: BOTE (Beginning Of The End) inflammation can be enhanced with SB206, a nitric oxide-releasing topical medication for molluscum contagiosum
Authors: Tomoko Maeda-Chubachi, MD, PhD, MBA, Martina Cartwright, PhD, Amy Paller, MD
Session: Concurrent 15
Date and Time: Saturday, May 21, 2022 at 11:45 AM ET

In June 2021, Novan reported statistically significant positive topline results for the primary efficacy endpoint (p-value <0.0001) of complete clearance of all treatable lesions in its B-SIMPLE4 pivotal Phase 3 clinical study of berdazimer gel, 10.3% for the treatment of molluscum. Additionally, and consistent with results from the Company’s prior Phase 2 and Phase 3 studies, berdazimer gel, 10.3% was found to be well tolerated in the B-SIMPLE4 study and met Company expectations. No treatment-related serious adverse events were reported.

BOTE sign observed in molluscum patients is known to be a sign of resolving molluscum contagiosum infection, but BOTE was never prospectively studied. Based on Novan’s B-SIMPLE4 study data, patients with a positive BOTE sign (BOTE+) at baseline had greater lesion reduction and clearance by Week 12 than patients with no BOTE or a negative BOTE sign (BOTE-) at baseline, supporting the hypothesis that BOTE sign predicts molluscum contagiosum resolution. Patients who were both BOTE+ at baseline and treated with berdazimer gel, 10.3% had the greatest chance of molluscum clearance. The mechanism by which nitric oxide release hastens molluscum clearance is unknown but may be due in part to immunomodulatory activity as indicated by induction of BOTE, although other mechanisms may be involved. For more information about the B-SIMPLE4 study, please visit clinicaltrials.gov and reference identifier: NCT04535531.

There are currently no FDA approved prescription therapies for the treatment of molluscum. The Company believes that berdazimer gel, 10.3% as a topical, prescription, self- or 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 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 medical dermatology company primarily focused on researching, developing and commercializing innovative therapeutic products for skin diseases. Our goal is to deliver safe and efficacious therapies to patients, including developing product candidates 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 current emphasis on molluscum contagiosum.

We recently completed the acquisition of EPI Health. EPI Health equips us with a robust commercial infrastructure across sales, marketing, and communications, as well as fully dedicated market access and pharmacy relation teams. Following the acquisition, we employ approximately 100 staff, including sales personnel currently covering 42 territories, and we promote products for plaque psoriasis, rosacea, acne and dermatoses. We also have a pipeline of potential 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; 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 and manufacturing 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, 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 are the results of the B-SIMPLE4 Phase 3 study for NOVN's berdazimer gel?

The B-SIMPLE4 study reported statistically significant positive results for the complete clearance of lesions in patients using berdazimer gel, with a p-value less than 0.0001.

When does NOVN plan to submit the NDA for berdazimer gel?

Novan aims to submit the New Drug Application (NDA) for berdazimer gel, 10.3%, by the end of 2022.

What is the significance of the BOTE sign observed in the B-SIMPLE4 trial?

The BOTE sign indicates a sign of resolving molluscum contagiosum infection, with patients showing this sign experiencing greater lesion reduction and clearance.

What is the unmet need for molluscum contagiosum therapies in the U.S.?

Currently, there are no FDA-approved prescription therapies for molluscum, affecting approximately six million people annually, primarily children.

What is berdazimer gel, and how does it work?

Berdazimer gel, 10.3%, is a nitric oxide-releasing topical medication aimed at treating molluscum contagiosum by enhancing inflammation and potentially accelerating infection clearance.