Novan has announced results from its two Phase 3 trials of SB204 gel 4%, its investigational candidate for the treatment of acne vulgaris.

SB204, a nitric oxide-releasing product, was examined in two trials (NI-AC301 and NI-AC302) for significant efficacy in changes of inflammatory and non-inflammatory lesion counts and proportion of patients achieving success on the Investigator Global Assessment (IGA) at week 12.

The trials randomized at total of 2,639 individuals with moderate to severe acne, in a 1:1 ratio to either SB204 Gel 4% topically once-daily or vehicle gel topically once-daily, for 12 weeks. 

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The absolute change from baseline in the number of non-inflammatory lesions was –15.4 for SB204 compared to –13.4 for vehicle (P=0.030; trial NI-AC301), and –14.9 for SB204 and –12.3 for vehicle (P=0.001; trial NI-AC302).

For inflammatory lesions, trial NI-AC301 demonstrated a reduction of –12.1 for SB204 and –11.1 for vehicle (P=0.114), in NI-AC302 reductions were –12.9 and –10.6, respectively. IGA success – defined as an improvement of at least two grades in the IGA score from baseline – was 13.4% for SB204 and 13.8% for vehicle (P=0.866; trial NI-AC301) and 18.9% and 14.3%, respectively, in NI-AC302 (P=0.032).

“While we are pleased with the results of the NI-AC302 trial that met the regulatory requirement […] we are disappointed with the discordant results of NI-AC301,” said Nathan Stasko, PhD, President and CEO of Novan. ““Despite these discordant results, we believe in the potential of nitric oxide’s multiple, well-documented mechanisms of action.”

In a statement Nova said they have enough funding for operating through the end of 2017, then the allocation of capital will be dependent upon further, ‘assessment of the SD204 Phase 3 results and data from other platform programs.’

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