Shares in Novan plunged as much as 74% after the company reported that two Phase III studies of the experimental drug SB206 for the treatment of molluscum contagiosum failed to meet their primary endpoints. However, Novan indicated that it plans to continue development of the topical nitric oxide-releasing compound, with a further late-stage trial scheduled to start in April, subject to additional funding.
The studies, dubbed B-SIMPLE1 and B-SIMPLE2, randomised a total of 707 patients aged six months and older with molluscum contagiosum to receive SB206 or vehicle. The trials' main goal is the proportion of patients with complete clearance of all treatable molluscum lesions at week 12, while secondary endpoints included complete clearance at week eight.
Top-line results showed that statistical significance was not achieved for the primary endpoint in either study, with 25.8% of SB206-treated patients in B-SIMPLE1 achieving clearance of all treatable molluscum lesions at week 12, versus 21.6% for vehicle. Meanwhile, in B-SIMPLE2, the rates were 30% for SB206 and 20.3% for vehicle, which Novan said was "near statistically significant."
The company explained that in B-SIMPLE2, SB206 demonstrated significance for the secondary endpoint, with 13.9% of patients achieving complete clearance at week eight, compared to 5.9% for vehicle. Novan said that B-SIMPLE2 was also significant for multiple pre-specified sensitivity analyses, adding that a number of sensitivity analyses are "supportive and consistent" across both studies and potentially allow for a path to advance SB206.
According to Novan, it plans to use B-SIMPLE2 as one of the confirmatory trials for a marketing application seeking clearance of SB206, subject to discussions with the FDA. The company indicated that it is still targeting a filing in the second quarter of 2021, depending on the outcome of the additional trial.
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