Novan announces beginning of phase 3 trial for acne treatment

Novan has announced in a press release that dosing has begun in its phase 3 trial of SB204 Gel, its topical nitric oxide product candidate, for treating acne vulgaris.

Two identical phase 3 trials are being conducted in parallel, and Novan expects to report the phase 3 results in the first half of 2017, according to the release.

“During the first patient in our phase 3 program for SB204 represents an important milestone of Novan in our development of our lead product candidate,” Nathan Stasko, PhD, president and CEO of Novan, said in the release. “It also represents a historic milestone for topical nitric oxide for dermatology. Never before has a nitric oxide-release macromolecule made it this far in develop, and, if approved, SB2-04 will be first new chemical entry specifically developed for treating acne in more than 20 years.”

Results were announced in 2015 for Novan’s maximal use pharmacokinetic study showing no detectable exposure to SB204, as well as a phase 2b study evaluating efficacy and safety of SB204, according to the release.

Novan’s phase 3 program for SB204 includes three trials. The two identical trials each have 1,300 patients, aged 9 years and older, with moderate to severe acne. The patients will received SB204 4% topically once daily or vehicle gel once daily. Absolute changes in inflammatory and non-inflammatory lesion counts and proportion of subjects with Investigator Global Assessment success at week 12 are primary endpoints, according to the release.

A long-term safety study will examine once-daily treatment with SB204 for patients who have completed 12 weeks of treatment, according to the release.

Reference: www.novan.com