Evofem Biosciences (EVFM) Reports Phase 3 EVOGUARD Trial of EVO100 Did Not Achieve Endpoints

Evofem Biosciences, Inc. (OTCQB: EVFM) announced today that the recently completed Phase 3 EVOGUARD clinical trial evaluating EVO100 for the prevention of chlamydia and gonorrhea infection in women did not achieve its endpoints.

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.

"We are disappointed that EVO100 did not achieve the desired outcome in this STI clinical trial, despite the data observed in our prior study," said Saundra Pelletier, Chief Executive Officer of Evofem. "The impact of the public health response to the COVID pandemic included universal recommendations for social distancing, individual and household quarantines, and clinic visits for health emergencies only. We believe changes in clinical site operations, subject behavior and actions including deviations from following the clinical study protocol requirements related to STI acquisition, detection, and prevention contributed to this outcome," added Pelletier.

"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 Dr. Brandi Howard.

"As the lead statistician on both the Company's EVOGUARD trial and the earlier Phase 2b/3 STI study, I am surprised by these study results and I believe COVID impacted the observed infection rates," said Clint Dart, VP, Biostatistics and Programming at Premier Research.

"Prevention trials are challenging in their own right, even absent a pandemic environment," noted Lisa Rarick, MD, FACOG, a practicing ObGyn, former FDA division director and Evofem board member. "I believe STI prevention is important to prove, but we must not lose sight of the fact that Phexxi is an FDA-approved product that is the first and only non-hormonal, on-demand, prescription contraceptive that empowers women to control their fertility, always, whenever they want to."

As previously reported, Evofem has experienced strong growth in net sales of Phexxi® (lactic acid, citric acid and potassium bitartrate), as well as market access expansion, as payers and pharmacy benefit managers (PBMs) continue to add Phexxi to their formularies, allowing women to fill their prescriptions immediately.

At this time, the Company 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 this STI clinical program due to financial resources.

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