Novan Therapeutics announced positive results from a phase 2b study of SB204, its topical nitric oxide-based candidate.
The trial demonstrated statistically significant reductions in the percent change of noninflammatory and inflammatory lesions at week 12 with all doses of SB204 compared with vehicle, according to a press release.
The phase 2b study was conducted across 20 sites in the United States, and included 213 patients who were randomly assigned to five treatment groups: SB204 2% twice daily, SB204 4% once daily, SB204 4% twice daily or vehicle once or twice daily. The patients received treatment for up to 12 weeks, the release reported.
A phase 2a study was held previously at four sites in Latin America, in which 153 subjects were randomly assigned to twice-daily treatment with SB204 1%, SB204 4%, or vehicle in a 1:1:1 ratio and treated for 12 weeks, the release reported.
Patients reported no treatment-related serious adverse events, according to the release. Less than 1% of all patients treated with SB204 or vehicle discontinued treatment because of local application site adverse events in both phase 2 trials.
“These study results reproduce our Phase 2a trial, which showed a similar separation between active drug and vehicle,” Nathan Stasko, PhD, Novan’s president, said in the release. “Replicating a 20% differential between SB204 and vehicle in percent lesion reduction gives us great confidence in moving into the phase 3 program.”
Based on the trial results, Novan announced plans to initate two phase 3 trials with SB204 once daily in the beginning of 2016, with 1,300 patients to be enrolled in each study.
“Novan’s SB204 product has shown promising tolerability and an impressive level of efficacy for a monotherapy that may limit resistance to antibiotics,” Steven Feldman, MD, PhD, at the department of dermatology, Wake Forest Baptist Medical Center, stated in the release.