This small company with propriatary nitric oxide medicines headquartered in Morrisville, North Carolina, Novan ($NOVN), is about to have a Type C meeting this week with the Food and Drug Administration (FDA) about their drug candidate SB206.
Novan is developing SB206 as a topical antiviral gel for the treatment of viral skin infections, with a current focus on the treatment of molluscum contagiosum, a contagious skin infection caused by the molluscipoxvirus.
Novan Phase 3 Molluscum Clinical Program
- Novan Reported Top-Line Efficacy Results from Phase 3 Trials of SB206 for Molluscum Contagiosum (B-SIMPLE1, B-SIMPLE2) in January 2020:
- SB206 failed to achieve statistically significant results for the primary endpoint.
- B-SIMPLE2 was statistically significant for multiple pre-specified sensitivity analyses.
- Similar analyses with B-SIMPLE1 demonstrated the trial is reasonably consistent and supportive of B-SIMPLE2.
- The safety profile of SB206 through the Week 12 visit was found to be favorable. Adverse events experienced in the B-SIMPLE program were primarily mild to moderate and the only treatment emergent adverse events (TEAE) reported in greater than 5% of subjects in the SB206 treatment arm were application site pain and application site erythema. There were no treatment-related serious adverse events reported in B-SIMPLE1 or B-SIMPLE2.
- All efficacy and safety data (both trials) including the prospectively planned safety evaluation through Week 24, targeted to be available in March 2020.
- FDA Type C Meeting scheduled for April 1, 2020, to seek feedback on the proposal to conduct one additional, well-controlled confirmatory study of SB206 to support a future NDA.
Novan Phase 2 Molluscum Clinical Trial Results
In a Phase 2 dose-ranging trial for the treatment of molluscum, clinical trial results include:
- For the primary endpoint, 12% once-daily was the most effective dose with 42% (mITT, p<0.05) and 38% (ITT, p<0.05) complete clearance rates compared to 20% and 18% for vehicle, respectively.
- For the secondary endpoint of mean percent change from baseline molluscum lesion count at each visit, patients treated with 12% once-daily experienced 29% (p<0.05), 37% (p<0.01), 56% (p<0.001) and 55% reductions in molluscum lesions at Week 2, 4, 8 and 12, respectively (mITT).
- No quantifiable levels of systemic exposure detected for SB206 12% twice-daily or once-daily following 12 weeks of treatment.
- The 12% once-daily treatment group had the lowest dropout rate out of all treatment groups, 9%, with 0 patients discontinuing treatment due to adverse event.
Novan’s Preclinical Data
- SB206 exhibited a dose responsive pharmacologic effect with complete inhibition of papilloma growth compared to topical imiquimod in an in vivo model.
- NVN1000, the active pharmaceutical ingredient in SB206, exhibited a dose dependent decrease in HPV viral replication in human raft cell culture model.
Novan’s Big Catalyst for Nitric Oxide Inhalent – Meets with FDA
Although this meeting is for seeking feedback on the proposal to conduct one additional, well-controlled confirmatory study of SB206 to support a future NDA. There are also catalyst for a nitric oxide inhalent based on a recent SEC filing.
There was a recent study of nitric oxide for SARS and COVID-19 coronavirus treatment and according to the study this type of treatment had high efficacy for respiratory illnesses like SARS and COVID-19 coronavirus .
Novan also recently closed an $8 million dollar direct offering and intends to use the net proceeds from the offering to fund its research and development programs and for general working capital purposes and other operating expenses.
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