Novan Inc. (NASDAQ:NOVN) has announced that it expects its current cash to be adequate to fund costs related to carrying its additional third phase pivotal SB206 study as a molluscum treatment or B-SIMPLE4 (Berdazime Sodium In Molluscum Patients with Lesions).
Novan has enough cash to commence B-SIMPLE4 study
Since the beginning of this year, Novan has secured a capital of around $16.9 million. The company secured the cash through common shares purchase transactions with Aspire Capital Fund as well as exercising of common stock warrants it sold in its public offering of March 2020. Novan is anticipating the commencement of the recruitment of the first subjects in the B-SIMPLE4 study by September this year. If the company succeeds in commencing the study as per the timeline without any delays due to the COVID-19 pandemic, the company is targeting the release of topline efficacy data towards the end of Q2 2021.
Paula Brown Stafford, the CEO and President of the company indicated that they are excited to be in a position to go on with the planned B-SIMPLE4 trial seamlessly. Stafford indicated that there is an unmet need for patients with molluscum as well as their caregivers. As a result, the company is looking forward to advancing the development of the SB206 program.
No FDA-approved therapy for molluscum treatment
So far, there are no FDA-approved molluscum treatment therapies. Some of the treatment options for patients, especially for most that are under 10-years, include physician-directed scraping, burning, blistering, and freezing treatment alternatives that are painful and conducted in-office. In contrast, the only other treatment alternative for these patients is over the counter products and off-label prescriptions. These alternatives do not have data supporting them for molluscum indication, and thus there is no proven safety profile and clinical efficacy.
Novan is optimistic that SB206 will be a beneficial at-home, caregiver-administered topical therapy with significant treatment benefit. Therefore this will satisfy a significant patient care need for molluscum treatment. The company leverages naturally occurring immunomodulatory and anti-microbial mechanisms of nitric oxide in treating various diseases.