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    Novel acne gel found safe in three clinical trials

    Dr. StaskoA nitric oxide-releasing gel to treat acne vulgaris has been found to be extremely safe, according to three Phase 1 pharmacokinetic clinical trials presented in April at the annual meeting of the Society for Investigative Dermatology in Portland, Oregon.

    SB204 gel is a topical nitric oxide-drug candidate in development by Novan Inc. The active pharmaceutical ingredient is NVN1000, the company’s new chemical entity.

    “Our gel has the potential to offer a totally new mechanism of action for acne disease,” says Nathan Stasko, PhD, co-founder, president and chief scientific officer of Novan. “The understanding of acne physiology is finally attaining the level of science and attention it deserves.”

    Dr. Stasko says for many decades now, there has been the same themes and types of products for treating acne. “Today, though, is a really important time in the acne space for patients because much of the same innovation that has occurred in psoriasis and atopic dermatitis is now being directed to acne,” Dr. Stasko tells Dermatology Times.

    One of the main new features of the acne gel is that nitric oxide has the potential to inhibit the NLRP3 inflammasome assembly and the downstream production of cytokines.

    “There are key cytokines in acne, like IL-1β, which have been shown to be the driving force in clogging the pores,” Dr. Stasko says. “We thought that if you could stop that process – the underlying inflammation – then you could possibly treat the disease in an entirely new way.”

    Dr. Stasko notes that retinoids have previously attacked this particular component of acne pathology. “However, retinoids accomplish this partly by shedding or peeling off the skin, from a top-down perspective,” he says.

    In contrast, nitric oxide remodels the skin from the bottom up, “in a much safer and gentler approach to treat the microcomedones,” Dr. Stasko says.

    The series of three safety clinical trials assessed the pharmacokinetics of the acne gel in subjects with acne.

    “The goal of these pharmacokinetics studies was to determine if there was any systemic exposure to the product, when applied liberally to a large surface area like the upper chest, the upper back, the face and the shoulders,” Dr. Stasko explains. “In other words, is the drug still safe when administered in a maximal use setting and is there any detectable exposure to the drug in the blood.”

    Several sophisticated analytical methods were developed by Novan to help clarify safety of the acne gel, according to Dr. Stasko.

    “The conclusion from all three of the studies is that there was no detectable analyte of our drug substance in any of the subjects at any of the time points, under maximal use conditions,” Dr. Stasko says.

    Next: Study details

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