MORRISVILLE, N.C.—Aimed at finding a treatment for the pain of psoriasis and other inflammatory skin diseases, late-stage pharma Novan Inc. reported recent preclinical data that show product candidate SB414 significantly reduced composite psoriasis scores—which consist of erythema and plaque scores—and pro-inflammatory cytokines, including interleukin-17 (IL-17), in a psoriasis mouse model.
There is no cure for psoriasis, but Novan thinks it could be the first to find a true path to relief of the skin disease’s symptoms—and it plans to accelerate clinical development of SB414 in large part based on these preclinical data.
“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,” stated Nathan Stasko, president and CEO of Novan, in a news release about the data. “Biologics have shown dramatic effects 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 percent of the total psoriasis patient population.”
“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,” Stasko adds. “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.”
Stasko has led the transformation of the company’s nitric oxide platform from the academic benchtop to Phase 3 clinical trials and is considered a leading expert in the field of nitric oxide. An inventor of the core Novan technology and author of more than 100 patent filings, 19 of which have been issued, Stasko has authored several peer-reviewed manuscripts pertaining to the chemical storage and controlled release of nitric oxide.
Stasko is also credited with leading Novan through each of its private financings totaling more than $100 million, government grants and contracts totaling $15 million, as well as assembling a team of professionals with drug development and commercialization expertise to position Novan as a commercially successful leader in the dermatology market.
According to a recent peer-reviewed article in the British Journal of Dermatology, IL-17, a key inflammatory cytokine, is known to be or is likely to be related to the mechanism and severity of a number of inflammatory skin disorders, including alopecia areata. The preclinical data Novan announced in late 2016 showed that SB414 reduced pro-inflammatory cytokines, including IL-17. However, SB414 has not been studied for the treatment of alopecia.
Dr. Bruce Strober, professor of dermatology, department chair and director of clinical trials at the University of Connecticut, states, “The evidence of clinical trials to date has shown a clear link between IL-17 inhibition and improved clinical outcomes for patients with psoriasis. “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.
For the approximately 80 percent of patients with mild-to-moderate psoriasis, prescription treatment options include topical corticosteroids, retinoids and vitamin D. None of the currently approved therapies are without side effects, and none are well-suited for chronic use.
Novan says its ability to harness nitric oxide and its multiple mechanisms of action has enabled the company to create a platform with the potential to generate differentiated, first-in-class product candidates, adding the company is rapidly advancing programs in five dermatological conditions with significant unmet medical needs.
“We believe that our ability to conveniently deploy nitric oxide on demand in topical formulations allows us the potential to significantly improve patient outcomes in a variety of skin diseases and positions us to be a commercially successful leader in the dermatology market,” the company says.