SB204 is a topical monotherapy in development for the treatment of acne vulgaris, a multi-factorial disease with varying disease pathology (inflammatory and bacterial). SB204 utilizes the same active pharmaceutical ingredient used in our lead product candidate, SB206, and is formulated specifically to address acne via an anti-inflammatory and anti-bacterial mechanism.
In two previous Phase 3 studies, AC301 and AC302, SB204 demonstrated consistent and promising results across two of three co-primary endpoints. In addition, AC302 was a successful pivotal trial with respect to all three co-primary endpoints, including non-inflammatory lesions, inflammatory lesions, and Investigator’s Global Assessment (IGA). Based on the recent positive pivotal Phase 3 results in the SB206 molluscum development program, Novan believes it can optimize the trial design of a pivotal Phase 3 study for SB204 which has the potential to serve as a second pivotal trial to support an NDA submission.
• AC302 was a successful pivotal Phase 3 trial across all three co-primary endpoints
• Consistent results across AC301 and AC302 for two of three co-primary endpoints
• Positive B-SIMPLE4 results validated our technology and our effective trial execution