Vaxart: Teslexivir Phase 2 Trial Fails To Meet Primary Efficacy Endpoint

(RTTNews) - Vaxart, Inc. reported the topline results from a Phase 2 clinical trial evaluating the safety and efficacy of an antiviral teslexivir 5% gel dosed topically twice daily in 218 subjects for the treatment of condyloma, or anogenital warts. The primary efficacy endpoint was defined as complete clearance of baseline condyloma by week 16. With respect to the primary efficacy endpoint, 30.6% of patients in the teslexivir group completely cleared baseline condyloma by week 16, compared to 23.3% of patients in the placebo group. The company said the difference was not statistically significant.

"While this trial did not achieve the primary efficacy endpoint, we were pleased with the benign safety profile and positive efficacy trends in certain patient subpopulations. We are currently in the follow-up phase of the study and data collection should continue for a few more weeks. During this period, we will conduct further analysis of the results, which should inform us about the future steps with the teslexivir program. In the meantime, we will continue to focus on the advancement of our oral vaccine platform through the clinic," said Wouter Latour, CEO of Vaxart.

The company said the analysis of the topline data demonstrated the study met all its primary safety objectives, with teslexivir showing a benign safety and tolerability profile, comparable to placebo.