Biotechnology firm Novan Inc's (NASDAQ: NOVN) share price has rocketed on Friday after it reported positive topline efficacy and safety results for the B-SIMPLE4 pivotal Phase 3 clinical study of SB206.
SB206 is a topical antiviral gel for the treatment of molluscum contagiosum.
The primary endpoint for the trial was the proportion of patients with complete clearance of all treatable molluscum lesions at Week 12. Novan confirmed that the study achieved statistical significance for the primary endpoint with a p-value less than 0.0001.
There were no severe or adverse events related to treatment with SB206 and Novan intends to submit New Drug Application (“NDA”) no later than the third quarter of 2022.
“The positive results from B-SIMPLE4 represent a transformational milestone for our employees, investors and most importantly, people living with molluscum,” said Paula Brown Stafford, President and CEO of Novan.
“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,” added Stafford.
There are no FDA approved therapies for molluscum treatment, and Novan believes that if approved, SB206 “would satisfy an important patient-care need.”
The company's shares have rocketed so far today, up 80.86% at $16.35.
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