Novan Releases Clinical Results for Skin Disease Treatment

Following a positive Phase 1b trial for SB414, Novan (NASDAQ:NOVN) announced on Monday (August 20) that it will move forward with testing indications.

The company’s trial for atopic dermatitis and psoriasis resulted in a decision to move forward with the development of a drug candidate for atopic dermatitis. Novan will also explore the use of lower doses in psoriasis and acne rosacea.

“We believe a larger, longer study in atopic dermatitis, further evaluation of psoriasis given the reduction of Th17 cytokines including IL-17, and exploration of nitric oxide in acne rosacea is warranted from a science, clinical and patient need point of view,” Tomoko Maeda-Chubachi, Novan’s vice president of medical dermatology, said in a press release.

The two randomized, double-blind, vehicle-controlled Phase 1b trials were aimed at testing target engagement through a reduction of key inflammatory biomarkers, and at evaluating the systemic exposure of SB414.

The trials also measured the safety, tolerability and initial efficacy endpoint of SB414 in patients. Patients in the trials were given either 2-percent SB414 cream, 6 percent or vehicle twice daily for two weeks.

Clinical efficacy measures in the trials were strongly linked with critical and disease-relevant biomarker changes, which suggests that a topical nitric oxide therapeutic may be able to recognize disease modification.

The clinical data from the atopic dermatitis trial will be submitted for future presentations by the management team.

SB414 is part of Novan’s technology platform and nitric oxide science product. Scientific papers in reference to dermatology have shown nitric oxide’s ability to regulate inflammation, revitalize tissue, increase local blood flow and kill bacteria.

In regards to preclinical data in a psoriasis mouse model, the drug candidate reduced composite psoriasis scores and inhibited the production of pro-inflammatory cytokines, including interleukin-17, or IL-17a and IL-17f.

Positive preclinical data was also found with the drug for atopic dermatitis disease pathology, including potent anti-staphylococcal activity in partial-thickness skin wounds infected with a methicillin-resistant S. aureus strain isolated.

Psoriasis is a chronic inflammatory skin disease described as an errant immune-system response that causes inflammation and thickening of the skin resulting from rapid skin cell turnover.

Patients suffering from the condition experience extreme discomfort from the infected skin, and it is often associated with an increased incidence of other diseases. Approximately 7.5 million people are affected by psoriasis in the US.

All of the current approved therapies for the disease have side effects and are not well suited for chronic use.

Atopic dermatitis, also called atopic eczema, is another inflammatory skin disease with symptoms including intense itching, dry skin with red papules and plaques, crust and scaling, among others. Eighteen million people in the US are affected by the disease.

Many current approved therapies are also not well suited for chronic use and focus on reducing the amount and severity of flareups associated with atopic dermatitis and psoriasis. Another recently approved biologic treatment targeting IL-4 and IL-13 is reserved for patients with moderate-to-severe atopic dermatitis disease.

Novan is a clinical-stage biotechnology company using its nitric oxide’s natural antiviral and immunomodulatory mechanism to treat dermatological and oncovirus-mediated diseases. Other product candidates Novan has in trials include SB204, SB206 and SB208 for acne vulgaris, molluscum and tinea pedis/onychomycosis, respectively.

Novan expects to release top-line results for molluscum during Q4 2018. The company will also meet with the US Food and Drug Administration (FDA) during the first half of 2019 pending the clinical results of SB206’s Phase 2 trial.

In addition, Novan is awaiting receipt of the FDA’s written feedback from its Type C meeting held with the organization in Q2 2018. The company is awaiting this feedback as a necessary component for the advancement of SB204 in acne.

Investor takeaway

Over the trading period on Monday, Noven’s share price decreased 3.27 percent, moving to US$2.37.

From analyst reports over the past three months, TipRanks predicts the company’s share price may increase to a high of US$14 or fall to a low of US$6.

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Securities Disclosure: I, Gabrielle Lakusta, hold no direct investment interest in any company mentioned in this article.