Novan Reports Topline Results from SB204 Phase 3 Pivotal Trials

  • Topical Acne Product Candidate Achieves Statistical Significance on All Three Co-Primary Endpoints in One Trial, Demonstrates Statistical Significance on Only One of Three in the Second

  • Company Continues to Analyze Trial Data to Better Understand These Results

Novan, Inc. (NASDAQ:NOVN) today announced  top-line results from the Company’s two, replicate Phase 3 pivotal clinical trials for SB204 in the treatment of acne vulgaris. In the intent-to-treat analysis, Novan’s topical nitric oxide-releasing product candidate SB204 demonstrated statistical significance (p<0.05) compared to vehicle on all three co-primary endpoints in NI-AC302, but demonstrated statistical significance on only one of three co-primary endpoints in NI-AC301. The three co-primary endpoints included the absolute changes in inflammatory and non-inflammatory lesion counts and proportion of patients achieving success on the Investigator Global Assessment, or IGA, at week 12. Success was defined as an improvement of at least two grades in the IGA score from baseline and an IGA score of 0 or 1, or “clear” or “almost clear.”