- Evofem Biosciences Inc's EVFM recently completed the Phase 3 EVOGUARD trial evaluating Phexxi vaginal gel (EVO100) to prevent chlamydia and gonorrhea infection in women but did not achieve its endpoints.
- CEO Saundra Pelletier, trial investigator Brandi Howard and study statistician Clint Dart all blamed the loss on COVID-19's impact on infection rates and patients' "risk behavior" in a press release.
- Evofem is ending further investment in the STI clinical program "due to financial resources," the company said.
- Evofem is expected to submit regulatory applications in the first half of 2023 to the FDA.
- In August, Evofem announced that the last subject had completed her last visit in the EVOGUARD trial.
- EVOGUARD builds on the positive, statistically significant outcomes of AMPREVENCE Phase 2b/3 study evaluating Phexxi for preventing chlamydia and gonorrhea.
- AMPREVENCE met its primary and secondary endpoints and showed that the product was generally safe and well-tolerated.
- Price Action: EVFM shares are down 39.60% at $0.10 on the last check Wednesday.
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