Novan Stock Plunges On Weak Trial Results Of SB206 For Molluscum Contagiosum

(RTTNews) - Novan Inc.'s (NOVN) shares plunged around 73 percent in the extended trading on Nasdaq after the company announced that phase III program with SB206 for the treatment of molluscum contagiosum has failed to achieve statistically significant results for the primary endpoint of efficacy.

The clinical development-stage biotechnology company noted that the phase III program, dubbed B-SIMPLE, consists of two trials namely, B-SIMPLE1 and B-SIMPLE2. The trials evaluated SB206 for the treatment of molluscum in 707 patients aged 6 months and older, with a 2:1 (active: vehicle) randomization. Statistical significance was not achieved for the primary endpoint in either B-SIMPLE1 or B-SIMPLE2.

Meanwhile, SB206 was near statistically significant for the primary endpoint in B-SIMPLE2, and was statistically significant in the secondary endpoint and several pre-specified sensitivity analysis.

Novan said the multiple sensitivity analyses are supportive and consistent across both studies and support a potential path forward for SB206.

The phase III B-SIMPLE program is ongoing, with full efficacy and safety data, including the prospectively planned safety evaluation ongoing through Week 24, targeted to be available by March 2020.

The company said it intends to utilize B-SIMPLE2 as one of the confirmatory trials for New Drug Application submission, subject to discussions with the U.S. Food and Drug Administration.

Further, the company intends to support and confirm B-SIMPLE2 with an additional confirmatory Phase 3 trial targeted to commence in April 2020, subject to additional funding and FDA feedback.

NOVN closed Thursday's trading at $3.11, down 1.58 percent. In after-hours, the stock was down 72.67 percent to $0.85.