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.


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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.

Reference

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.

This article originally appeared on MPR