Novan’s antiviral gel, SB206, failed in two phase 3 trials in patients with molluscum contagiosum.
Molluscum contagiosum is a contagious skin infection caused by the molluscipoxvirus, commonly found in children. There are no FDA approved therapies for molluscum.
Following the news, shares of the North Carolina-based biotech fell 72 percent in premarket trading and the company also announced it it only has enough cash to support operations through the first quarter of this year.
But Novan has not quite given up. According to the company, "Statistical significance was not achieved for the primary endpoint in either B-SIMPLE1 or B-SIMPLE2, however multiple sensitivity analyses are supportive and consistent across both studies and support a potential path forward for the asset."
Since one of the trials was approaching statistical significance, the company intends to support and confirm B-SIMPLE2 with an additional confirmatory Phase 3 trial targeted to commence in April 2020 — pending additional funding and FDA feedback.
Read the press release
