And a big rise in the share price also !!!! Here is the News release:
Novan Reports Positive Topline Results from Pivotal Phase 3 Trial of SB206 in Patients with Molluscum Contagiosum
2021-06-11 03:30 PT - News Release
– B-SIMPLE4 achieves statistical significance for the primary endpoint with p-value less than 0.0001 –
– No serious adverse events related to treatment with SB206 –
– Novan intends to submit New Drug Application (“NDA”) no later than the third quarter of 2022 –
– Management to host video webcast today at 8:00 a.m. ET –
DURHAM, N.C., June 11, 2021 (GLOBE NEWSWIRE) -- Novan, Inc. (“the Company” or “Novan”) (Nasdaq: NOVN), today announced positive topline efficacy and safety results for the B-SIMPLE4 pivotal Phase 3 clinical study of SB206, a topical antiviral gel, for the treatment of molluscum contagiosum (“molluscum”). Molluscum is a common, contagious skin infection caused by the molluscipoxvirus, affecting approximately six million people in the U.S. annually, with the greatest incidence in children aged one to 14 years. The Company will host a video webcast, today, June 11, 2021, at 8:00 a.m. ET (details below) to discuss the results of the study.
“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,” commented Paula Brown Stafford, President and Chief Executive Officer of Novan. “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.”
B-SIMPLE4 is a multi-center, double-blind, randomized, vehicle-controlled study that exceeded its enrollment target by randomizing 891 patients (1:1 randomization) in the study, across 55 clinical sites. Patients were treated for up to 12 weeks with a follow-up visit at Week 24. The primary endpoint for the study is the proportion of patients with complete clearance of all treatable molluscum lesions at Week 12 (Intent-to-Treat or “ITT” population, where the analysis assumes that patients with missing data at Week 12 are considered treatment failures).