First patient dosed in Novan's Phase 3 program to evaluate efficacy of SB204 Gel in treatment of acne

Feb 23 2016

Novan, Inc. today announced that the first patient has been dosed in its Phase 3 program to evaluate the efficacy and safety of its topical nitric oxide product candidate SB204 Gel in the treatment of acne vulgaris ("acne"). The Company is running two identically designed Phase 3 pivotal trials in parallel and expects to report top-line results in the first half of 2017.

"Dosing the first patient in our Phase 3 program for SB204 represents an important milestone for Novan in the development of our lead product candidate," said Nathan Stasko, PhD, President and Chief Executive Officer of Novan. "It also represents a historic milestone for topical nitric oxide and for dermatology. Never before has a nitric oxide-releasing macromolecule made it this far in development, and, if approved, SB204 will be the first new chemical entity specifically developed for the treatment of acne in more than 20 years. We believe that this truly first-in-class investigational monotherapy has the potential to redefine the standard of care for acne, and we are eager for the results of these trials."

Results from Novan's maximal-use pharmacokinetic study showing no detectable systemic exposure to SB204 as well as the Company's Phase 2b study evaluating the efficacy and safety of SB204 for the treatment of acne were announced in June and September 2015, respectively.