"We store nitric oxide on a polysiloxane backbone, using our proprietary Nitricil technology, and then we can tune the timing and duration of the NO release via our formulation science."
What is the vision you are currently pursuing for Novan?
Our vision is to be the world’s leading nitric oxide-based science, technology and clinical translation company. Our proprietary technology came out of the University of North Carolina Chapel Hill in 2008, and we currently have a pipeline consisting of multiple drug product candidates. We are determined to harness the power of this technology to develop safe and efficacious therapies.
What is unique about Novan’s Nitricil technology platform?
Nitric oxide is a heavily researched molecule, but there have been challenges associated with controlling the release of the gas and the ability to stabilize and store it. That is what Novan has been able to do with our NO Platform. We store nitric oxide on a polysiloxane backbone, using our proprietary Nitricil technology, and then we can tune the timing and duration of the NO release via our formulation science. This two-part component of our platform requires a hydrogen donor source to begin the release process, which is tuned based on specific formulations. The formulation science is such that when you combine them, or when the donor source mixes with nitric oxide that is sitting on that backbone, it launches, and then it becomes active. This is why the technology is proprietary, innovative, and novel. Each of our candidates are based on this technology.
Can you outline the unmet medical need Novan is addressing for Molluscum patients?
Molluscum is not a terminal disease. However, it is highly contagious. It is shared within families, between teammates and in situations where children are having a lot of contact, and it can spread to become as many as 100 lesions. When you have lesions all over your body the only thing you can do is wait or request an in-office procedure. On average, it takes 13 months for it to resolve on its own. However, many have lesions for a much longer period of time. Our product candidate could allow these patients to put the medication on their lesions every morning for up to 12 weeks and it could give them a solution far quicker than if they were waiting for it to resolve on its own.
Can you provide an update on the B-Simple 4 Pivotal Phase 3 Study of SB206? What were some of the key adjustments made from the previous trial?
We ran B-SIMPLE 1&2, which were two phase three protocols in 2019, with results at the beginning of 2020. While they had directionally positive data, they were not statistically significant. We saw a treatment difference, but it was not a statistical treatment difference between our product and our placebo because we know with the placebo that patients will eventually clear. Fortunately, we saw separation as early as week two post baseline. However, in one trial the p-value was 0.062, very close to the magical 0.050. We went to the FDA and they told us we needed to run one more trial that is below a 0.050 p-value. If these results come in, then they will consider the better of those studies to be the confirmatory trial.
What is Novan’s strategy for the potential commercialization of SB206?
We want to keep our options open. Being a publicly traded company, we want to make the right decision for our shareholders and bring them the highest return possible. We also want to bring a product to market for patients. For us, it is about deciding whether or not we do it ourselves or in some form of a partnered approach. If we do commercialize it ourselves, we most likely will partner with a contract sales and marketing organization. We are also keeping options open to out-license. We have a licensed partner in Japan, for instance, and we could potentially partner in the US, Canada, Mexico, or elsewhere. We are keeping those options open, and waiting on results until we make that decision.