Novan completes enrollment for phase 3 trials of SB204 gel

Novan completed enrollment for its two identically designed phase 3 clinical trials to evaluate the efficacy and safety of its topical nitric oxide-releasing product candidate SB204 gel for the treatment of acne, according to a press release.

The NI-AC301 and NI-AC302 12-week parallel trials will each include approximately 1,300 patients aged 9 years and older who will be administered SB204 gel 4% topically once daily.

The Novan phase 3 program also will include a subsequent study, NI-AC303, for the long-term safety in eligible patients who have completed 12 weeks of treatment in the NI-AC301 or NI-AC302 trial.

“We are extremely pleased with the rapid enrollment of these phase 3 trials for our lead product candidates,” Nathan Stasko, PhD, president and CEO of Novan, said in the release. “We believe the physicians and their patients deserve a new option for the treatment of this chronic inflammatory skin disease, and we are eager for the results of these trials.”

Primary endpoints include absolute changes in inflammatory and noninflammatory lesion counts and proportion of patients with Investigator Global Assessment success at 12 weeks, according to the release.

Novan expect to report top-line results in the first quarter of 2017.

Reference: www.novan.com