Happy family on a couch

SB204

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  involving 4 key pathophysiological factors including inflammation and bacterial colonization.1 SB204 utilizes the same active pharmaceutical ingredient used in berdazimer gel 10.3% (SB206), and is formulated specifically to address acne via an anti-inflammatory and anti-bacterial activity.2
Close-up of acne
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, Pelthos 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.

Program Highlights:

  • 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

Acne Market

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.

~50 million

People with
acne in the U.S.3

～$2.9 billion

Topical U.S. acne market (products
and combos)4

Acne has significant physical and psychological morbidity, such as permanent scarring, poor self-image, depression and anxiety

 

1.  Vasam M, Korutla S, Bohara RA. Acne vulgaris: A review of the pathophysiology, treatment, and recent nanotechnology based advances. Biochem Biophys Rep. 2023;36:101578. Published 2023 Nov 23. doi:10.1016/j.bbrep.2023.101578  2. Baldwin et al Dermatol Ther. 2019;9(4):725–734 3. 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. 4. IMS National Prescription Audit MAT Feb. 2016 – Acne Prescription Market TRx Dollars – MAT Feb 2016.