Novan Therapeutics nitric oxide-based acne gel SB204 is safe, according to data presented at the 23rd World Congress of Dermatology in Vancouver, Canada.
SB204 was generally well-tolerated and not associated with any significant safety issues under maximal use conditions in a Phase 1 clinical study in adults with moderate-to-severe acne. Moreover, there was no evidence of systemic exposure, the study showed. Nitric oxide may help treat acne by cooling inflammation and killing microorganisms.
The Phase 1 study assessed the pharmacokinetics and safety of SB204 Gel applied topically to the chest, back, and face of adults with moderate to severe acne vulgaris. Subjects meeting entry criteria were administered SB204 8% or Vehicle Gel twice daily during the 5-day treatment period. Serial blood samples were collected on Days 1 and 5 and analyzed for systemic exposure. After a washout period, subjects were administered the alternate treatment over 5 days, with the same blood sampling schedule.
Top-line results of US Phase 2b trial with SB204 in 200 subjects with acne are expected by the third quarter of this year. The Phase 3 pivotal clinical trials with SB204 should begin in the first quarter of 2016.
Novan Therapeutics recently secured $50 million in private financing.