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Novan's gel therapy fails in late-stage skin infection studies

Novan Inc. said SB206 was not significantly better than a so-called vehicle in treating a skin condition called molluscum contagiosum.

Morrisville, N.C.-based Novan said the drug failed to meet its primary endpoints under the B-Simple program, which is made up of two phase 3 clinical studies called B-Simple1 and B-Simple2. The trials enrolled a total of 707 patients aged 6 months and older, and the company evaluated the efficacy of the drug after 12 weeks of treatment.

Molluscum contagiosum is a common viral infection of the skin that results in firm, painless bumps. The infection can spread easily and is usually self-treatable.

In B-Simple1, 25.8% of patients reported complete clearance of all treatable molluscum lesions compared to 21.6% for the vehicle group. In B-Simple2, 30.0% of those that received SB206 reported the same compared to 20.3% for the vehicle group.

The two trials are ongoing, and the company is awaiting 24-week safety data. The company expects to report full efficacy and safety data from both trials by March of this year.

Given B-Simple2's results, Novan said it plans to use the study as one of the confirmatory trials in support of U.S. approval of the medicine, which it will seek in the second quarter of 2021. Novan will also conduct an additional confirmatory phase 3 trial — expected to begin in April — for that reason, subject to additional funding and feedback from the U.S. Food and Drug Administration.

When breaking down the results by multiple sensitivity analyses, Novan said trial results support a potential path forward for the asset. This includes evaluating the medicine in select patient populations from within the trial, such as the so-called per-protocol or intent-to-treat patients where SB206 was near statistically significant for the primary endpoint in B-Simple2.

Novan said the company continues to explore both financial as well as strategic options to advance SB206 in the molluscum indication. The company had $22.5 million in cash, cash equivalents and restricted cash as of Sept. 30, 2019 — sufficient to fund operations in the first quarter of 2020, excluding the sale of the company's stock to investor Aspire Capital Fund LLC. "The company is working to further address current operations with the aim of achieving a reduction in near term cash expenditures. Substantial additional funding will be required in order to continue to sustain business operations," Novan said in a statement.