Novan (NOVN) Completes Enrollment in Pivotal SB204 Phase 3s

September 28, 2016 8:33 AM EDT
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Novan, Inc. (Nasdaq: NOVN) announced that the last patient has been randomized in the Company's two, identically designed Phase 3 pivotal clinical trials to evaluate the efficacy and safety of topical nitric oxide-releasing product candidate SB204 Gel in the treatment of acne vulgaris, or acne. Novan announced in February that the first patient had been dosed in these trials. Per the study protocol, the last patient randomized will be treated for 12 weeks. The Company is running the two Phase 3 pivotal trials in parallel and expects to report top-line results in the first quarter of 2017.

"We are extremely pleased with the rapid enrollment of these Phase 3 trials for our lead product candidate," said Nathan Stasko, PhD, President and Chief Executive Officer of Novan. "If approved, SB204 will be the first new chemical entity specifically developed for the treatment of acne in more than 20 years and, in our view, has the potential to redefine the standard of care for acne. We believe physicians and their patients deserve a new option for the treatment of this chronic inflammatory skin disease, and we are eager for the results of these trials."

Results from Novan's Phase 2b study evaluating the efficacy and safety of SB204 for the treatment of acne were presented in March by Lawrence Eichenfield, MD, during a Late-breaking Research in Dermatology Forum at the 74th Annual Meeting of the American Academy of Dermatology.1

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