Novan announced that the first patient has been dosed in its Phase 3 trial to evaluate the efficacy and safety of its topical nitric oxide product candidate SB204 Gel in the treatment of acne vulgaris. The company anticipates reporting the results from the two identically designed Phase 3 pivotal trials in the first half of 2017.
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 study in subjects with moderate to severe acne across 55 sites in the U.S. Approximately 1,300 subjects, ages 9 and older, 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.
“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,” said Nathan Stasko, PhD, president and CEO of Novan. “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.”
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