Evofem announces AMPREVENCE trial meets primary, secondary endpoints
Evofem announced top-line results from AMPREVENCE, a Phase 2b clinical trial evaluating the efficacy and safety of Amphora for the prevention of urogenital chlamydia and gonorrhea in women. The study met both its primary and secondary endpoints of reducing the risk of chlamydia and gonorrhea infection, respectively, and demonstrated that Amphora was generally safe and well tolerated. In this study, the infection rate of chlamydia among women who used Amphora for the four-month study period was 4.9% compared to 9.8% among those who used placebo for four months, a relative risk reduction of 50% in the primary endpoint. Among the reported cases of gonorrhea infection, the infection rate was 0.7% in the Amphora arm, compared to 3.2% in the placebo arm, a relative risk reduction of 78% in the secondary endpoint. Amphora was generally safe and well tolerated in this study population, consistent with previous trial results for use of this investigational drug for pregnancy prevention. The number of adverse events was similar across both arms and no serious treatment-related adverse events were reported. Top-line results are based on a preliminary analysis of currently available efficacy and safety data. Further analysis is ongoing and final results are subject to change based on a comprehensive review by the company and the FDA. The company expects to submit full results for presentation at an upcoming scientific meeting. These data will also form the basis for an End-of-Phase 2 meeting request with the FDA.