Positive Phase IIb study results for the investigational topical nitric oxide drug SB204 (Novan Therapeutics) for the treatment of acne vulgaris demonstrated statistically significant reductions in the percent change of non-inflammatory and inflammatory lesions at Week 12 with all doses of SB204 compared to vehicle.
SB204 demonstrated excellent cutaneous tolerability with no treatment-related serious adverse events in over 400 dosed subjects to date. Based on these results and having completed an End-of-Phase 2 meeting with the FDA, the company plans to initiate 2 pivotal Phase 3 trials with SB204 once daily in the first quarter of 2016, targeting enrollment of 1,300 subjects per trial.
