Novan Announces Favorable Preclinical Safety Data and Intent to Advance SB019 for Treatment of COVID-19

Rhea-AI Summary

Novan has announced positive preclinical results for its intranasal formulation SB019 containing berdazimer sodium, indicating it is well-tolerated in a 14-day GLP toxicity study. These findings support the advancement of SB019 toward human clinical trials, with an IND submission planned by Q2 2022. The study showcased significant efficacy in reducing SARS-CoV-2 transmission in preclinical models, suggesting potential for COVID-19 and other respiratory infections. The company is focused on obtaining financing and strategic partnerships to further develop this therapy.

Positive

• Well-tolerated SB019 formulation in 14-day GLP toxicity study.
• Promising efficacy observed in reducing SARS-CoV-2 transmission.
• IND submission planned by Q2 2022 to initiate Phase 1 human trials.
• Potential for further applications against respiratory infections.

Negative

• None.

– Data indicate that intranasal administration of SB019 formulation containing berdazimer sodium is well-tolerated and safe under the conditions of preclinical study –

– Company believes the promising conclusions from this Good Laboratory Practices (GLP) study support advancement of the SB019 program toward in-human clinical development –

– Pre-IND (Investigational New Drug) application activities are underway with a target of an IND submission no later than Q2 2022 –

DURHAM, N.C., Nov. 09, 2021 (GLOBE NEWSWIRE) -- Novan, Inc. (“the Company” or “Novan”) (Nasdaq: NOVN), today announced promising preclinical safety results with berdazimer sodium in a 14-day GLP repeat dose intranasal toxicity study. These findings compliment the previous positive preclinical efficacy results observed in deterring transmission from SARS-CoV-2-infected golden Syrian hamsters. The Company is continuing to progress the development of its potential anti-viral therapy against COVID-19, the disease caused by the SARS-CoV-2 virus.

To further evaluate the potential of its NITRICIL™ platform technology as an intranasal treatment option for COVID-19, the Company initiated preclinical in vivo studies evaluating the safety and toxicity of berdazimer sodium when intranasally administered via the SB019 formulation. The GLP study evaluated repeated dosing with the candidate product SB019 (i.e., 5 times daily) for a period of 14 days and concluded with a 7-day recovery period without drug exposure. There were no treatment-related adverse events up to the highest dose tested of 14 mg/day berdazimer sodium and the SB019 formulation was concluded to be well-tolerated under the conditions of this study.

“These preclinical data support and further strengthen the rationale behind developing SB019 as a potential intranasal therapeutic against COVID-19. Through engagement with the Coronavirus Treatment Acceleration Program, or CTAP, we have made the FDA aware of our SB019 program and our intent to submit an IND. We remain focused on the next steps to submit an IND and initiate a Phase 1 study in humans no later than the second quarter of 2022,” commented Paula Brown Stafford, President and Chief Executive Officer of Novan.

Intranasal administration of berdazimer sodium marks a notable extension to previously assessed routes of exposure preclinically (e.g., dermal, oral, and intravenous) or clinically used in the assessment of the safety and tolerability of berdazimer sodium, across the Company’s numerous programs.

“Beyond our commitment to COVID-19, demonstrating that berdazimer sodium can be well-tolerated when administered intranasally unlocks numerous potential opportunities to assess the efficacy of the NITRICIL™ platform technology in additional indications, such as influenza, respiratory syncytial virus (RSV), or other respiratory-related infections,” remarked Dr. Carri Geer, Chief Technology Officer.

The Company has also completed additional dose-range finding studies in SARS-CoV-2 infected golden Syrian hamsters through work conducted at the Institute for Antiviral Research at Utah State University. Significant reduction in the amount of virus in lung or nasal tissue of animals directly inoculated and infected with SARS-CoV-2 was observed and found to be dependent on both the concentration and dosing regimen (e.g., once daily vs. twice daily) of intranasally administered berdazimer sodium. These findings, coupled with the promising safety data announced today for dosing up to five times daily, will inform potential human clinical trial design.

The Company continues to evaluate the potential progression of SB019, subsequent to its anticipated Phase 1 study, subject to obtaining additional financing or through strategic partnerships.

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,” “intends” 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, the Company’s intention to advance development of certain product candidates, including the potential for SB019 as an anti-viral therapy against COVID-19, the potential safety and tolerability of the Company’s product candidates, the Company’s intention to pursue discussions with the FDA regarding a regulatory pathway for SB019 and submit an IND and the Company’s intention to partner with third parties. 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, including the timing and outcome of discussions with the FDA; 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; 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 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; any operational or other disruptions as a result of the COVID-19 pandemic; 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 SB019 preclinical study?

The SB019 formulation containing berdazimer sodium showed positive safety results and was well-tolerated in a 14-day GLP toxicity study.

When does Novan plan to submit the IND for SB019?

Novan targets to submit the IND for SB019 no later than Q2 2022.

What is the significance of the preclinical study for Novan's SB019?

The study supports the advancement of SB019 for human clinical trials and indicates its potential as an anti-viral therapy against COVID-19.

What potential markets could Novan's SB019 address?

In addition to COVID-19, SB019 could be applied to treat other respiratory infections like influenza and RSV.