Evofem : Phase 3 Trial Of EVO100 In Chlamydia And Gonorrhea Infection Fails To Achieve Endpoints

(RTTNews) - Evofem Biosciences Inc. (EVFM.OB) said that Phase 3 EVOGUARD clinical trial, which evaluated EVO100 for the prevention of chlamydia and gonorrhea infection in women, did not achieve its endpoints.

According to the company, the product safety profile was consistent with what has been observed in prior clinical trials, and only two women (0.1%) in the study discontinued due to adverse events.

The company said it will focus on continuing to meet the unmet contraceptive need of millions of women with Phexxi but will discontinue further investment in the development of the STI clinical program due to financial resources.

The EVOGUARD trial was a Phase 3, double-blind, placebo-controlled efficacy trial of Phexxi vaginal gel for the prevention of urogenital Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) infection. A total of 1903 women, ages greater than or equall 18, who had a documented urogenital CT or GC infection or an undocumented self-reported CT or GC infection with risk factors, at any time over the 17 weeks preceding the enrollment visit, or positive at screening visit were enrolled. Enrolled subjects were randomized 1:1 to receive either EVO100, 5g or placebo, 5g, supplied in a pre-filled, single-dose applicator, immediately before or up to one hour prior to coitus for the duration of the 16-week intervention period.