In Development For The Treatment Of Acne Vulgaris
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, berdazimer gel 10.3% (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 berdazimer gel 10.3% (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
We believe among dermatology health-care providers there remains a significant unmet need for novel mechanisms of action with favorable tolerability profiles to improve patient outcomes in acne.
acne in the U.S.1
Topical U.S. acne market (products
Acne has significant physical and psychological morbidity, such as permanent scarring, poor self-image, depression and anxiety
- Bickers DR, Lim HW, Margolis D, Weinstock MA, Goodman C, Faulkner E et al. The burden of skin diseases: 2004 a joint project of the American Academy of Dermatology Association and the Society for Investigative Dermatology. Journal of the American Academy of Dermatology 2006;55:490-500.
- IMS National Prescription Audit MAT Feb. 2016 – Acne Prescription Market TRx Dollars – MAT Feb 2016