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Novan's SB204 Could Be First Topical Sebum Inhibitor



2/28/2013 10:53:50 AM

DURHAM, N.C., Feb. 28, 2013 /PRNewswire/ -- Novan Therapeutics, a clinical-stage drug development company, today announced in vitro and animal testing data indicating that the company's drug candidate, SB204, could lead to a topical treatment to reduce oil production in the skin. SB204 is being developed as a new therapy for acne which is the most common skin disease in the United States, affecting more than 50 million people.

(Logo: http://photos.prnewswire.com/prnh/20130228/NE68367LOGO )

None of the current topical products approved by the FDA reduce the production of sebum, the oily/waxy secretions of the skin. Dr. Diane Thiboutot, Professor of Dermatology at Penn State Hershey College of Medicine, believes "Inhibiting the production of sebum is critical to affecting the acne disease process. Orally administered therapies that can reduce oily secretions of the skin have traditionally shown good clinical responses. At this time, I am not aware of any topically applied therapy that can reduce sebum production."

Novan-sponsored research conducted in the lab of Dr. Thiboutot revealed that nitric oxide-releasing compounds could reduce sebum production in vitro using immortalized human sebocytes. The study results demonstrated that Novan's drug candidate showed a statistically significant decrease in insulin-induced lipid production as early as 24 hours after a single treatment.

In a separate study to further expand upon the company's unique discovery, topical application of nitric oxide-releasing SB204 inhibited the growth of a hamster flank organ by more than 50% compared to vehicle control. "We are really excited about these results because this now gives us two potential pathways by which SB204 can shut down the production of sebum in the skin," said company President Dr. Nathan Stasko. The golden Syrian hamster flank organ model has historically been used to assess the anti-androgenic activity of experimental therapeutics. The overproduction of androgens in the skin has been linked to the overproduction of sebum and worsening of acne.

Novan expects to begin enrolling subjects in a Phase 2 study for the treatment of acne in the second quarter of this year. This clinical study will evaluate the safety and efficacy of SB204 as well as the topical therapy's ability to decrease sebum in the skin of subjects. Dr. Stasko commented, "We have invested significant resources to develop methods for the clinical evaluation of sebum in the skin. SB204 could be an attractive topical acne treatment and what we believe will be the first of many innovative products for the field of dermatology."

About Novan, Inc.

Novan Inc., based in the Research Triangle Park area of North Carolina, is a clinical-stage drug development company harnessing the power of nitric oxide. Nitric oxide, one of the most studied molecules in human physiology, has been confirmed to promote vasodilation, regulate inflammation, revitalize tissue, kill invading microorganisms, and even eradicate cancer. The company's proprietary platform technology enables the stable storage of nitric oxide and the ability to deliver its healing power to patients in a variety of dosage forms. Novan is currently developing innovative, first-in-class therapies for the field of dermatology.

For more information, please contact:

Julia Brannan
Pascale Communications
201-725-7375
novan@pascalecommunications.com
www.novantherapeutics.com

SOURCE Novan Therapeutics


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