Novan, Inc. has announced preclinical data showing that its nitric oxide-releasing product candidate SB414 significantly (p<0.05) reduced composite psoriasis scores, which consist of erythema and plaque scores, and pro-inflammatory cytokines, including interleukin-17, or IL-17, in a psoriasis mouse model.

“These data represent a significant advancement of Novan’s platform, not only for the treatment of psoriasis, but also for the treatment of several other inflammatory skin diseases,” said Nathan Stasko, PhD, President and Chief Executive Officer of Novan. “Biologics have shown dramatic effect against psoriasis in clinical trials but carry a risk-benefit profile that has reserved their use for patients with moderate-to-severe disease, or approximately 20% of the total psoriasis patient population.¹ The newer biologics that target IL-17, such as secukinumab and ixekizumab, have dramatically elevated the field’s understanding of the disease pathology and clinical outcomes for patients. We believe that a topical treatment utilizing Novan’s nitric oxide-releasing technology may be able to disrupt the propagation of IL-17 locally in the skin and deliver clinical benefit without the systemic exposure and side effects of biologics. This is an exciting opportunity, and as a result we plan to accelerate clinical development of SB414.”

“The evidence of clinical trials to date has shown a clear link between IL-17 inhibition and improved clinical outcomes for patients with psoriasis,” said Dr. Bruce Strober, board-certified dermatologist, professor of dermatology, department chair and director of clinical trials at the University of Connecticut. “The broader connection of IL-17 to multiple inflammatory skin disorders would seem to suggest a novel approach for clinical developers and new hope for patients suffering from these diseases.”

Based on the data generated in this preclinical in vivo study, Novan expects to initiate clinical development with a Phase 2 proof-of-concept trial of SB414 as a topical treatment for psoriasis in the second quarter of 2017.