What You Need to Know About Novan Therapeutics

What You Need to Know About Novan Therapeutics
November 13, 2015
By Alex Keown, BioSpace.com Breaking News Staff

Novan Therapeutics, spun out of the University of North Carolina (UNC), is developing dermatological treatments for acne and other skin conditions using nitric oxide therapies. Nitric oxide is produced by the body and has been shown to be effective in killing the bacteria associated with acne. Historically, the benefits have been somewhat short-lived, but Novan believes its researchers have found a method to increase the benefits. Durham N.C.-based Novan believes it has solved delivery issues for nitric oxide-based treatments by “stably storing the gaseous species on macromolecules that result in a diverse pipeline of timed-release nitric oxide-releasing new chemical entities. Novan has approximately 50 employees.

But the company has its sights set on more than using its nitric oxide therapies for dermatological use. BioSpace spoke to Nathan Stasko, president and co-founder of Novan, and Stasko said he anticipates the therapies having applications for use in oncological treatments, but the company has yet to pursue that avenue.

Company Pipeline
Novan Therapeutics has two experimental therapies in mid-stage development. Both therapies are nitric oxide based treatments. The first, SB204, is to treat acne vulgaris. The topical acne treatment successfully completed Phase II, which “demonstrated statistically significant reductions in the percent change of non-inflammatory (white heads and black heads) and inflammatory (larger red bumps and pustules) lesions at Week 12 with all doses of SB204,” the company said in a statement. Stasko said he anticipates Phase III results in early 2017.

Novan’s SB206 is a topical anti-viral that the company believes could lead to a treatment for human papillomavirus (HPV) infections. The drug is currently in Phase II testing for the treatment of genital warts. Novan said current treatments for genital warts have several shortcomings, including discomfort, modest efficacy and recurrence. Novan’s preclinical in vivo data demonstrated that “high-dose SB206 resulted in complete (100%) inhibition of papilloma growth over the entire treatment period.” Stasko said there are some good HPV treatments on the market, but most of them have a “watch and wait paradigm.” He said he believes the therapies being developed by Novan will be able to overcome that and show an immediate effect on the virus. Stasko said Novan expects topline results for the Phase II tests of SB206 in the third quarter of 2016.

In addition to its current pipeline treatments, Stasko told BioSpace the company is expecting to launch mid-stage trials exploring the use of the nitric-oxide treatments for fungus ailments. Early results have shown that nitric oxide penetrates the nail much quicker than standard treatments and could speed up treatment time.

“Nitric oxide will penetrate the nail almost instantly, while others take up to two weeks to penetrate the nail,” Stasko said. So, we’re seeing nitric oxide as an anti-bacterial, an anti-viral and an anti-fungal treatment.”

Market Competition
There is currently little market competition for nitric oxide in the dermatological field, but Canadian-based Valeant Pharmaceuticals International Inc. has developed a nitric oxide glaucoma treatment called Vesneo, which has been submitted to the U.S. Food and Drug Administration (FDA) for regulatory approval.

Still, Stasko said Novan is definitely the leader in the field of nitric oxide therapies.

“There are other companies that may have some technologies, or who have looked at the approach, but… there aren’t many companies in the class of nitric oxide where we are,” Stasko said.

Company Financing
In March, Novan received $50 million in funding from several investors, including Malin Corporation PLC, which has been slated to advance SB204, the company’s experimental treatment for acne vulgaris, through Phase III trials. The company said it expects to begin Phase III trials in the first quarter of 2016. That funding round was on top of $20 million the company had previously raised, Stasko said.

Portions of the funding are also expected to be used to finance the clinical development of SB206.

Stasko told BioSpace that Novan is preparing for another round of financing in early 2016.

Deals and Dollars
So far, Novan has primarily fostered relationships with academic researchers, including Neil Christensen, a microbiologist at Pennsylvania State University, who leads that university’s cancer medical research program. Novan is also working with researchers at the University of Alabama-Birmingham, who are researching the human papillomavirus.

Stasko said so far all of their work has been with other university programs, but company officials “remain enthusiastic” about collaborations with pharmaceutical and biotech companies.

Company Leadership
Nathan Stasko – The president and co-founder of Novan Therapeutics, Stasko is an inventor of the core Novan technology as well as many patent filings relating to drug substances, finished dosage formulations, methods of treatment and macromolecular drug delivery.

Richard PetersonNovan’s chief financial officer, formerly served as CFO of Medicis Pharmaceutical Corporation until its acquisition by Canada-based Valeant Pharmaceuticals International Inc. . During his time at Medicis, the company saw growth in revenue and profitability with a suite of products including the acne medication Solodyn. Prior to joining Medicis, Mr. Peterson was a senior financial auditor with PricewaterhouseCoopers.

Brian JohnsonNovan’s chief commercial officer, Johnson leads Novan’s commercialization efforts including sales, marketing and managed care for the company’s dermatology products. Before coming to Novan, Johnson held sales leadership positions at Ortho Pharmaceuticals, a division of Johnson & Johnson and Galderma Laboratories LLC where he served as vice president of prescription marketing and chief digital officer.

M. Joyce RicoNovan’s chief medical officer and board certified dermatologist, Rico has served on the faculty of several noted universities, including Duke and Northwestern. Rico has more than 12 years’ experience in product development. While at Fujisawa Astellas, Rico helped develop and launch products treating acne, eczema, and psoriasis as well as anti-infectives.

What to Watch For
Novan’s nitric oxide products have the potential to go far beyond dermatological therapies. Stasko said most of their product experience was built around dermatological visions, but, he added company leadership believes the therapies can be adapted into treatments for more malignant issues, including various solid tumor cancers.

“If this works in the skin, translating this into other treatments is a concept we plan to follow,” Stasko said.

This profile is part of an ongoing series here at BioSpace highlighting smaller biotech companies carving out a niche in the industry.

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