Evofem Completes Enrollment in EVOGUARD Phase 3 Clinical Trial of EVO100 for Prevention of Chlamydia and Gonorrhea in Women
-- EVOGUARD remains on track for topline data readout later this year
SAN DIEGO, March 4, 2022 /PRNewswire/ -- Evofem Biosciences Inc., (Nasdaq: EVFM) announced today that it has completed enrollment in EVOGUARD, the registrational Phase 3 clinical trial evaluating EVO100 (the investigational name for Phexxi® (lactic acid, citric acid, potassium bitartrate)) for two potential new indications: the prevention of chlamydia infection in women and the prevention of urogenital gonorrhea infection in women.
The clinical trial design initially called for an enrollment of 1730 participants. Due to the high level of demand to enter the study, investigators enrolled 1903 participants, providing the potential for a more comprehensive understanding of the trial data and outcomes.
Top-line data from EVOGUARD are expected in the second half of 2022.
"I am seeing a significant increase in the number of chlamydia and gonorrhea infections in my patients," said Dr. Todd Chappell, an investigator for the EVOGUARD trial and practicing obstetrician and gynecologist. "There's a notable need for new, effective and safe ways to prevent these infections, and Phexxi, a potential preventive option against these contagious diseases may offer women a form of protection against these infections."
The CDC estimates that 4.0 million and 1.6 million new cases of chlamydia and gonorrhea, respectively, occurred in 2018 alone.1 The number of reported cases is lower than the estimated total number because infected people are often unaware of, and do not seek treatment for their infections. Almost 60% of women infected with chlamydia have no symptoms.2 Chlamydia is the most frequently reported bacterial infection in the U.S. and can infect both men and women. It can cause serious, permanent damage to a woman's reproductive system and make it difficult or impossible for a woman to become pregnant later in life.
Chlamydia and gonorrhea have been reported to be responsible for one-third to half of pelvic inflammatory disease (PID) cases. PID can cause serious, long-term problems including infertility, ectopic pregnancy, and chronic pelvic pain.3
Completion of enrollment comes less than a month after the U.S. Food and Drug Administration (FDA) awarded "Qualified Infectious Disease Product" (QIDP) Designation to EVO100 (the investigational name for Phexxi) for the prevention of urogenital chlamydia infection in women. QIDP designation is intended to encourage development of new products for the treatment of serious or life-threatening infections. A drug or product in development that receives this designation qualifies for an additional five years of marketing exclusivity following FDA approval for that indication.
"Completing enrollment in EVOGUARD marks a major milestone for Evofem and highlights our continuing efforts to evaluate this potential first and only-in-class product in women for the prevention of chlamydia and gonorrhea infections," said Saundra Pelletier, CEO of Evofem Biosciences. "As we speak with women and observe the market environment, we recognize the need to educate the public about these two sexually transmitted infections and are working to seize the opportunity and expand our role in helping women control and protect their sexual health. If approved, Evofem can make an impact beyond preventing unplanned pregnancy, and realize a sizeable new market opportunity."
The FDA previously granted EVO100 Fast Track Designation for the prevention of both chlamydia and gonorrhea, and in 2017 awarded QIDP Designation to EVO100 for the prevention of gonorrhea in women.
Evofem remains grateful to all those taking part in and conducting the EVOGUARD trial, and all other ongoing Evofem-sponsored research.
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About Evofem Biosciences
Phexxi® is a registered trademark of Evofem Biosciences, Inc.
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SOURCE Evofem Biosciences, Inc.
Company Codes: NASDAQ-NMS:EVFM