Positive topline results were announced from a pivotal phase 3 study evaluating SB206, a topical antiviral gel, for the treatment of molluscum contagiosum.
SB206 is an investigational nitric oxide-releasing topical gel that contains berdazimer sodium plus a hydrogel. The addition of a hydrogel promotes the release of nitric oxide upon application.
B-SIMPLE4 is a multicenter, randomized, double-blind, vehicle-controlled study (ClinicalTrials.gov Identifier: NCT04535531) evaluating the efficacy and safety of SB206 in 891 patients 6 months of age and older with molluscum contagiosum. Patients were randomly assigned 1:1 to receive either SB206 12% (n=444) or vehicle gel (n=447) topically once daily for up to 12 weeks. The primary endpoint was the proportion of patients with complete clearance of all treatable molluscum lesions at week 12.
Results demonstrated that SB206 met the primary endpoint, with 32.4% of patients achieving complete clearance of all lesions at week 12 compared with 19.7% of those treated with vehicle gel (P <.0001). Additionally, a greater proportion of SB2016-treated patients achieved a lesion count of 0 or 1 at week 12 (43.5% vs 24.6% with vehicle; P <.0001), 90% clearance of lesions at week 12 (43% vs 23.9% with vehicle; P <.0001), and complete clearance of all lesions at week 8 (19.6% vs 11.6% with vehicle; P =.0014).
The investigational gel was found to be safe and well tolerated. There were no treatment-related serious adverse events reported in the study.
Tomoko Maeda-Chubachi, MD, PhD, MBA, Senior Vice President, Medical at Novan commented, “With 32% of patients experiencing total clearance at week 12 and 43% of patients with total clearance or 1 remaining lesion at week 12, I am pleased to say the data demonstrate SB206 can be a powerful treatment option to shorten the duration of this contagious disease with visible skin lesions that worry parents and caregivers.”
The Company plans to submit a New Drug Application to the Food and Drug Administration by the third quarter of 2022.
Novan reports positive topline results from pivotal phase 3 trial of SB206 in patients with molluscum contagiosum. [press release]. Durham, NC: Novan, Inc.; June 11, 2021.