Novan Announces Successful Phase 2b Clinical Trial Results with SB204 for the Treatment of Acne Vulgaris
First-in-Class Nitric Oxide-Based Acne Therapy Set to Begin Phase 3 Trials in Early 2016
Novan Therapeutics announced today positive Phase 2b study results of its topical nitric oxide drug candidate SB204 for the treatment of acne vulgaris, achieving the company’s program goals. The Phase 2b study 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 compared to Vehicle. SB204 demonstrated excellent cutaneous tolerability with no treatment-related serious adverse events in over 400 dosed subjects to date. Across the entire Phase 2 development program, less than 1% of enrolled subjects treated with active or vehicle were discontinued due to local application site adverse events.
“These study results reproduce our Phase 2a trial which showed a similar separation between active drug and vehicle,” said Nathan Stasko, Ph.D., Novan’s president. “Replicating a 20% differential between SB204 and Vehicle in percent lesion reduction gives us great confidence in moving into the Phase 3 program.”