NOVAN: First Patient Dosed in Phase 3 Program for SB204
The first patient has been dosed in a Phase 3 study of Novan’s investigational topical nitric oxide acne gel, Novan, Inc. reports.
Novan is running two identically designed Phase 3 pivotal trials in parallel to evaluate the efficacy and safety of SB204 Gel for acne vulgaris. Top-line results are expects in the first half of 2017.
Nitric oxide may help treat acne by cooling inflammation and killing microorganisms. In addition, it reduces sebum production, and affects the keratinocytes without increasing the risk of antibiotic resistance.
“Never before has a nitric oxide-releasing macromolecule made it this far in development, and, if approved, SB204 will be the first new chemical entity specifically developed for the treatment of acne in more than 20 years,” says Nathan Stasko, PhD, President and Chief Executive Officer of Novan, in a news release. “We believe that this truly first-in-class investigational monotherapy has the potential to redefine the standard of care for acne, and we are eager for the results of these trials."
Novan's Phase 3 program includes three studies:
NI-AC301
"A Phase 3 Multi-Center, Randomized, Double-Blinded, Vehicle-Controlled, Parallel Group Study Comparing the Efficacy, Tolerability and Safety of SB204 and Vehicle Gel Once Daily in the Treatment of Acne Vulgaris" is a 12-week, double-blind, placebo-controlled, parallel group study in subjects with moderate to severe acne across 55 sites in the United States. Approximately 1,300 subjects, ages 9 and older, who satisfy the entry criteria will be randomized in a 1:1 ratio to two treatment arms, SB204 4% topically once daily or Vehicle Gel topically once daily. Primary endpoints include absolute changes in inflammatory and non-inflammatory lesion counts and proportion of subjects with Investigator Global Assessment (IGA) success at week 12. Secondary endpoints include percent changes in inflammatory and non-inflammatory lesion counts, time to reduction in inflammatory lesion count and time to improvement in IGA.
NI-AC302
"A Phase 3 Multi-Center, Randomized, Double-Blinded, Vehicle-Controlled, Parallel Group Study Comparing the Efficacy, Tolerability and Safety of Once Daily SB204 and Vehicle Gel in the Treatment of Acne Vulgaris" is an identically designed parallel study to NI-AC301.
NI-AC303
"A Phase 3 Multi-Center, Open-Label Study Evaluating the Long-Term Safety of SB204 Once Daily in the Treatment of Acne Vulgaris" is a long-term safety study in eligible patients who have completed 12 weeks of treatment in the NI-AC301 or NI-AC302 trials.