- The stock price of Novan Inc (NASDAQ: NOVN) has increased by over 30% pre-market. These are the details.
The stock price of Novan Inc (NASDAQ: NOVN) has increased by over 30% pre-market. Investors are responding positively to the company announcing 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 is known as a common contagious skin infection caused by the molluscipoxvirus, affecting about 6 million people in the U.S. annually, with the greatest incidence in children aged one to 14 years.
B-SIMPLE4 is a multi-center, double-blind, randomized, vehicle-controlled study that exceeded the enrollment target by randomizing 891 patients (1:1 randomization) in the study, across 55 clinical sites. And 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).
This is the summary of the primary and secondary endpoint results:
Consistent with results from the company’s Phase 2 and earlier Phase 3 studies, SB206 was found to be safe and well-tolerated. And no treatment-related serious adverse events (TEAE) were reported.
There are currently no U.S. Food and Drug Administration (FDA) approved therapies for the treatment of molluscum. And 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.
“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. 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.”
— Paula Brown Stafford, President and Chief Executive Officer of Novan
“This is an exciting day for both Novan, the treatment landscape of molluscum and the millions of people, primarily children, affected every year. 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.”
— Tomoko Maeda-Chubachi, M.D., Ph.D., M.B.A., Senior Vice President, Medical at Novan
“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.”
— John Browning, M.D., F.A.A.D, F.A.A.P., MBA, Adjunct Associate Professor of Pediatrics and Dermatology at UT Health San Antonio and Baylor College of Medicine, and a Principal Investigator in the B-SIMPLE4 study.
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