The B-SIMPLE4 phase 3 trial achieved positive efficacy results for the treatment of molluscum contagiosum.
Novan announced the results from B-SIMPLE4 (NCT04535531), a multi-center, double-blind, randomized, vehicle-controlled, phase 3 study evaluating the safety and efficacy of SB206 (Novan) for the treatment of patients with molluscum contagiosum. Molluscum contagiosum affects 6 million people in the United States, with highest incidence in children 1 to 14 years.
The study enrolled 891 patients randomized 1:1 across 55 clinical sites. Each patient received treatment for 12 weeks and had a follow up visit at week 24.
“The positive results from B-SIMPLE4 represent a transformational milestone for our employees, investors and most importantly, people living with molluscum. The strong safety and statistically significant efficacy results give us confidence as we move forward in preparing a New Drug Application to potentially bring SB206 to market and to patients in need of an effective therapy,” said Paula Brown Stafford, president and CEO of Novan, in Durham, North Carolina. “We owe a great deal of gratitude to the collaborative efforts of our employees, partners, CROs, study investigators and participating patients who have contributed or participated in B-SIMPLE4.”
The primary endpoint of the trial was a proportion of patients with complete clearance of molluscum lesion at week 12. Of the 444 patients who were a part of the SB2016 treatment arm, 32.4% were clear by week 12 compared to 19.7% of the patients treated with vehicle.
The secondary endpoints were a proportion of patients who achieved a lesion count of 1 or 0 at week 12. Results showed the proportion achieving 90% or more clearance of lesions at week 12, and the complete clearance of lesions at week 8. The SB206 also outperformed the vehicle cream on all secondary endpoints.
“These results are a testament to Novan’s solid execution of the SB206 clinical program and strategy, and our belief in the potential of SB206 to provide patients with treatment benefit. With 32% of patients experiencing total clearance at week 12 and 43% of patients with total clearance or one 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,” said Tomoko Maeda-Chubachi, MD, PhD, MBA, senior vice president of Medical at Novan, in Durham, North Carolina.
Currently, there are no FDA approved treatments for molluscum contagiosum.
“I am proud to have been an investigator in this pivotal study. The results are better than I could have imagined. I am excited to potentially have a topical treatment that is safe and effective in treating molluscum for my patients,” said John Browning, MD, FAAD, FAAP, MBA, adjunct associate professor of pediatrics and dermatology at University of Texas Health San Antonio and Baylor College of Medicine, in San Antonio, Texas, and a principal investigator in the B-SIMPLE4 study.
1. Thomas J. Novan Reports Positive Topline Results from Pivotal Phase 3 Trial of SB206 in Patients with Molluscum Contagiosum. Published online June 11, 2021.