Evofem Biosciences concludes Phase 2b Amphora 'AMPREVENCE' trial in women for chlamydia and gonorrhea; Expects to report top-line results in November 2019.

M2 EQUITYBITES-August 26, 2019-Evofem Biosciences concludes Phase 2b Amphora 'AMPREVENCE' trial in women for chlamydia and gonorrhea; Expects to report top-line results in November 2019

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Biopharmaceutical company Evofem Biosciences Inc (NASDAQ:EVFM) reported on Friday that it has dosed the last patient under its Phase 2b AMPREVENCE clinical trial evaluating its lead product candidate Amphora for the prevention of chlamydia and gonorrhea in women.

Amphora, which is a multipurpose vaginal pH regulator (MVP-R), is being studied by the company for the prevention of acquisition of chlamydia and gonorrhea in women (as primary and secondary endpoints, respectively).

According to the CDC, rates of infection with Chlamydia trachomatis and Neisseria gonorrhea climbed in 2017 for the fourth consecutive year in the US. Further, gonorrhea is increasingly becoming antibiotic resistant, making it much harder, or sometimes impossible, to treat.

AMPREVENCE is a double-blind, placebo-controlled, Phase 2b trial that enrolled 860 women who had been treated for chlamydia or gonorrhea in the four months preceding enrollment in the study. About 50 US centres participated in this unprecedented trial.

In conjunction, the subjects were randomized to either Amphora or placebo vaginal gel treatment arms. The primary and secondary endpoints of the study are the prevention of acquisition of urogenital Chlamydia trachomatis and Neisseria gonorrhea, respectively, concluded the company.

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