Novan Completes Phase 3 Enrollment for Molluscum Pivotal Program

Novan (NASDAQ:NOVN) has announced it has completed enrollment of its ongoing B-SIMPLE Phase 3 pivotal trials of SB206 to treat molluscum contagiosum.

As quoted in the press release:

The trials enrolled approximately 680 patients with 3 to 70 molluscum lesions at Baseline. The primary efficacy endpoint of the trials is complete clearance of all treatable molluscum lesions at Week 12, and follow-up will include a Week 24 safety assessment.

The SB206 results from Phase 2, previously announced in December 2018, demonstrated a clear treatment effect on the complete clearance of all molluscum lesions at Week 12 for 12% once-daily SB206 gel. There were signs of efficacy as early as Week 2, and the Phase 2 trial showed a favorable safety profile. For the primary endpoint, 12% once-daily was the most effective dose with 38% (ITT, p<0.05) complete clearance rates compared to 18% for vehicle.

“The pace by we which we fully enrolled these pivotal studies demonstrates the underlying demand and unmet medical need that exists for molluscum patients and their caregivers,” commented Elizabeth Messersmith, Ph.D, Senior Vice President and Chief Development Officer. Dr. Messersmith further commented, “The Novan team, along with the investigators and program coordinators, have done an exceptional job in achieving this important milestone. We look forward to sharing the top line results at the appropriate time.”

Click here to read the full press release.