Novan Announces Promising Results of SB204 Clinical Study
Phase 2 Clinical Results Expected Early 2014
DURHAM, N.C. – Novan Therapeutics, today announced results from a recent clinical trial demonstrating that nitric oxide releasing drug candidate SB204 reduces colonization of the acne causing bacteria Propionibacterium acnes (P. acnes) in the skin of healthy volunteers. This study in combination with Novan's earlier findings regarding sebum production, suggests the formulation may be capable of targeting multiple factors in acne.
The Phase 1, thirty-subject study was conducted by Dr. James Leyden (KGL, Inc.). This predictive human model has been used to demonstrate the activity of anti-acne therapies like traditional oral antibiotics and topical antibiotics such as clindamycin. In this study, twice daily administration of the topical product was safe and "the treatment was extremely well tolerated," added Dr. Leyden. Several subjects demonstrated a greater than 90 percent reduction of P. acnes when treated with SB204; no vehicle-treated subjects exhibited such a response. A statistically significant difference (p < 0.05) in P. acnes counts was observed between active and vehicle after two weeks.
Acne is the most common skin disease in the United States, affecting more than 50 million people. Antibiotics have been a mainstay for dermatologists due to the ability to reduce P. acnes colonization in the skin and the documented ability to treat inflammatory lesions in acne patients. However, monotherapy usage of these drugs has slowed due to the onset of antibiotic resistance. Nitric oxide is an antimicrobial with a low propensity for resistance and is part of the human body's natural immune response to bacteria. "These unique properties of nitric oxide, in conjunction with the potential to reduce sebum, provide the basis for our belief that SB204 has the possibility to transform acne care," says Dr. Nathan Stasko, Novan President.
"I have always said the 'Holy Grail' of acne treatments would be a topical that can influence sebum production or the physicochemical properties of sebum. If you can do that, the ability to kill P. acnes is icing on the cake," said Dr. Leyden.
SB204 is currently being examined in a Phase 2 study for the treatment of acne. Results of that study are expected early 2014.
About Novan, Inc.
Novan Inc., based in the Research Triangle Park area of North Carolina, is a clinical-stage drug development company focused on topical delivery of nitric oxide. Nitric oxide, one of the most studied molecules in human physiology, has been shown to exhibit anti-microbial activity and to promote vasodilation, regulate inflammation, stimulate tissue repair, and even eradicate cancer cells. The company's proprietary platform technology enables the stable storage and release of nitric oxide in a variety of dosage forms. Novan is currently developing innovative, first-in-class therapies for the field of dermatology.
Julia Brannan, Pascale Communications, LLC, on behalf of Novan Therapeutics