Vaxart Reports Topline Results from Phase 2 Trial of Teslexivir™ for the Treatment of Condyloma
Safety and tolerability profile comparable to placebo
Primary efficacy endpoint not achieved - Positive trend in two important subgroups
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. Adverse events and local skin reactions in the teslexivir group were also comparable with placebo, with mostly mild adverse events in both groups. No serious adverse events were observed. Early treatment termination, which we consider an important marker of product tolerability, was minimal with only 1.4% of patients discontinuing in either group.
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 difference was not statistically significant. In preliminary subgroup analysis, the rate of complete baseline condyloma clearance trended higher in female patients (37.5% teslexivir versus 23.3% placebo) and in patients with large condylomas (30.0% teslexivir versus 15.4% placebo), although results were not significant in either group.
“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,” said
A number of patients remain in the 3 month follow-up assessment period
of the study. Following the completion of the last patient visit in the
follow-up recurrence assessment period and the cleaning and lock of that
portion of the study,
About the Teslexivir Trial
This teslexivir trial was a Phase 2 double-blind, randomized, placebo-controlled trial designed to evaluate the safety, tolerability and efficacy of teslexivir 5% gel in male and female patients with condyloma, or anogenital warts. 218 female and male patients with 2-30 external condyloma were randomized in a 2:1 ratio, with randomization stratified on gender, to be dosed twice daily for up to 16 weeks with teslexivir or placebo gel. Condyloma and local skin tolerability were measured and assessed by investigators at study visits occurring 2, 4, 6, 9, 12 and 16 weeks following randomizations and initiation of dosing. If subjects cleared all condyloma prior to the end of 16 weeks, they proceeded directly to the 3-month untreated safety follow-up phase to assess for condyloma recurrence. The primary efficacy endpoint was to determine the complete clearance rate for baseline anogenital warts from the commencement of therapy to the end of the treatment period. Secondary efficacy endpoints include various assessments of clearance, time to clearance, and wart area reduction for both baseline warts and post-baseline emergent warts (i.e. all condyloma).
Teslexivir is a topical antiviral agent that is a potent and selective inhibitor of the interaction between two essential viral proteins, E1 and E2, an interaction that is a necessary step for human papilloma virus (HPV) DNA replication and thus viral production.
About Condyloma (Anogenital Warts)
Condyloma infections from HPV represent the most frequent viral sexually
transmitted disease in adults worldwide, with >95% of condyloma caused
by HPV 6 and 11. In
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