December 22, 2015
By Alex Keown, BioSpace.com Breaking News Staff
DURHAM, N.C. – Christmas came a little early for Novan Therapeutics in the form of a $30 million round of funding to advance its dermatological treatments for acne and other skin conditions using nitric oxide therapies.
In an earlier interview with BioSpace , Nathan Stasko, president and co-founder of Novan, said he expected a new round of funding for the company in the early part of 2016, but perhaps Santa delivered new financing earlier than anticipated. As it is though, Novan has not disclosed the name of its investors in its filing with the Securities and Exchange Commission. Additionally, Novan is mum on how it aims to use the financing to advance its therapies, the Triangle Business Journal reported.
In March Novan, a spin out of the University of North Carolina, 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. The topical acne treatment successfully completed Phase IIb, 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.
Portions of the funding are also expected to be used to finance the clinical development of SB206, 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 said the company is expecting to launch mid-stage trials exploring the use of the nitric-oxide treatments for to 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 told BioSpace. So, we’re seeing nitric oxide as an anti-bacterial, an anti-viral and an anti-fungal treatment.”
There is currently little market competition for nitric oxide in the dermatological field, but Canadian-based Valeant Pharmaceuticals has developed a nitric oxide glaucoma treatment called Vesneo, which has been submitted to the U.S. Food and Drug Administration for regulatory approval. The FDA is expected to rule on Vesneo in July 2016.
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.
