Share price of two phase III clinical failures of novan antiviral drug sb206 plummeted by 74%

Fan Dongdong Recently, novan announced that its antiviral drug sb206 failed to beat placebo in two phase 3 clinical trials (b-simple1 and b-simple2) for the treatment of Infectious Soft warts The black swan incident directly reduced the market value of novan by 74% Founded in 2006 and headquartered in North Carolina, novan is committed to redefining skin care standards through the development and commercialization of innovative therapies using the nitric oxide technology platform At present, the company's nitric oxide technology platform has produced a number of Dermatology candidate drugs, including sb206 SB206 is a local antiviral drug for the treatment of external genital organs and perianal condyloma acuminatum It consists of gels containing water and Berta sim These two components can promote the release of nitric oxide It is understood that about 700 participants were recruited in the two studies and randomly assigned to receive sb206 or local placebo once a day After 12 weeks, the researchers evaluated whether there were any infectious soft warts left in the patients However, the result is collapsing In both trials, sb206 did not have a statistically significant advantage over placebo in the complete removal of Infectious Soft warts, and did not reach the primary end point Novan seems to have a different view of the results of this experiment Novan pointed out that the p value of one of the tests was 0.062, which was statistically significant In addition, combined with positive results for the secondary end point (clearance at week 8), novan believes that the analysis of the test results is sufficient to meet the data needs for FDA approval Although the second study did not produce sufficient data, it could not be used as a confirmatory test But novan said the results of the second study were equally encouraging Novan plans to launch another phase 3 trial in April this year If the study produces positive results, the company will use it as a validation test and submit an application to FDA in 2021.