EVFM - Evofem's Phexxi fails in phase 3 trial to prevent chlamydia gonorrhea in women

Evofem Biosciences ( OTCQB:EVFM ) said a phase 3 trial of EVO100 (vaginal gel Phexxi) to prevent chlamydia and gonorrhea infection in women did not achieve its goals and that the company will not invest further in the development of STI clinical program due to financial resources.

The study called EVOGUARD enrolled 1903 women and evaluated Phexxi vaginal gel for preventing urogenital Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) infection versus placebo.

Phexxi (lactic acid, citric acid and potassium bitartrate) is a hormone free birth control vaginal gel approved in the U.S. to prevent pregnancy.

The main goal was proportion of people, among the modified Intent to Treat (mITT) population, who were negative for CT and GC at enrollment and were provided with study product who successfully completed the 16 weeks without any chlamydia or gonorrhea infection.

Evofem CEO Saundra Pelletier said that the company believes that changes in clinical site operations, patient behavior, deviations from study protocol requirements related to STI acquisition, detection, and prevention contributed to this outcome.

"As clinical study lead for the Phase 2b/3 AMPREVENCE STI trial and the Phase 3 EVOGUARD trial, I believe the study environment changed significantly from the AMPREVENCE trial to the EVOGUARD trial, specifically subject risk behaviors as well as site and CRO turnover. In a non-COVID environment, I believe the results would have likely been different, and that infection rates would have been higher in the placebo arm, as was seen in AMPREVENCE," said Brandi Howard in an Oct. 12 press release.

Evofem noted that the product safety profile was consistent with what was seen in prior trials, and only two women (0.1%) in the study discontinued due to adverse events.

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