• B-SIMPLE2 trial was statistically considerable for numerous pre-specified sensitivity analyses.
• Similar assessments with B-SIMPLE1 showed reasonably supportive and consistence results of B-SIMPLE2.

Novan, Inc., a clinical-stage biotechnology firm, has reportedly declared top-line efficacy results from its Phase 3 B-SIMPLE clinical study with SB206 for the treatment of molluscum contagiosum. Despite failing to attain statistical significance in the primary endpoint in B-SIMPLE1 or B-SIMPLE2, multiple sensitivity assessments were seen consistent and supportive in the two trials. Furthermore, these trials are currently ongoing as the firm waits for the 24-week safety data.

Basically, the B-SIMPLE program comprises of two multi-center, double-blind, randomized, vehicle-controlled clinical trials of a topical nitric oxide-releasing candidate, SB206 for treating molluscum in 707 patients aged six months and older, along with a 2:1 (active: vehicle) randomization.

Reportedly, Novan plans to utilize B-SIMPLE2 as one of the confirmatory trials for NDA (New Drug Application) submission, subject to discussions with the U.S. FDA (Food and Drug Administration). The company would commence an additional confirmatory Phase 3 trial for B-SIMPLE2 in April 2020, subject to additional FDA feedback and additional funding.

Moreover, depending on the outcome of discussions with FDA and confirmatory results in the additional trial, Novan’s timeline for new drug application submission would stay consistent and aims potential NDA submission in the 2nd quarter of 2021.

Meanwhile, safety and full efficacy data from both trials, comprising the prospectively planned safety assessment ongoing through Week 24, are aimed to be available by March 2020.

Incidentally, Novan has also recently announced submission of a pre-IND meeting with the FDA for product candidate, SB207. The company has identified targeted viral opportunities of high unmet needs of nitric oxide-releasing technology for patients. Its SB207 product integrates its current drug substance, berdazimer sodium, with a new formulation specifically engineered to be effective within several viral indications.

Source Credit - https://novan.gcs-web.com/node/8356/pdf