Novan Announces Final Week-12 Visit for Last Patient in B-SIMPLE4 Pivotal Phase 3 Study of SB206 for Treatment of Molluscum
– Topline data on track for readout before the end of Q2 2021 –
– Currently no FDA-approved therapies for the treatment of molluscum –
– Potential for NDA filing no later than Q3 2022 –
DURHAM, N.C., May 03, 2021 (GLOBE NEWSWIRE) -- Novan, Inc. (“the Company” or “Novan”) (Nasdaq: NOVN), today announced the final patient has completed their last Week-12 visit in the B-SIMPLE4 pivotal Phase 3 clinical study of SB206, a topical antiviral gel, for the treatment of molluscum contagiosum (“molluscum”). Topline efficacy and safety results from the B-SIMPLE4 study are targeted to be reported before the end of the second quarter of 2021.
“We are incredibly pleased with the progress we have continued to make as we advance our lead program. We remain focused on executing our remaining steps according to plan and reporting topline efficacy and safety data in June. On behalf of Novan, I would like to extend our sincere gratitude to the patients, families and clinical staff that have participated in the study,” commented Paula Brown Stafford, President and Chief Executive Officer of Novan. “Each patient will visit their physician one more time, at Week 24, and the study is expected to fully complete in the third quarter, although no additional efficacy data will be collected at that time.”
“There remains an unmet need in the treatment landscape of molluscum, which affects millions of people each year and primarily children under the age of 10. Our product candidate, SB206, represents a promising opportunity to provide patients with treatment benefit and address the unmet needs in the treatment landscape for molluscum. Depending on the results of the B-SIMPLE4 Phase 3 trial, we are targeting a potential NDA filing no later than the third quarter of 2022,” stated Tomoko Maeda-Chubachi, M.D., Ph. D., M.B.A., Senior Vice President, Medical at Novan.
B-SIMPLE4 is a multi-center, double-blind, randomized, vehicle-controlled study. The Company exceeded its enrollment target by randomizing 891 patients (1:1 randomization) in the study, across 55 clinical sites, due to the number of patients in screening at the time of achieving the planned enrollment goal. Patients have been 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 analsis assumes that patients with missing data at Week 12 are considered treatment failures).
There are currently no U.S. Food and Drug Administration (“FDA”) approved therapies for the treatment of molluscum. The Company believes that SB206 as a topical, at-home, self or caregiver-applied therapy with a rapid treatment benefit, if approved, would satisfy an important patient-care need for the treatment of molluscum.
For more information about the B-SIMPLE4 study, please visit clinicaltrials.gov and reference identifier: NCT04535531.
STIR/SHAKEN: The Deadline is Here, Are You Ready?
Session Details Coming Soon