Biopharmaceutical company Evofem Biosciences recently announced completion of last subject last visit (LSLV) in its registrational phase 3 clinical trial evaluating EVO100 (Phexxi®; lactic acid, citric acid, and potassium bitartrate) vaginal gel for the prevention of chlamydia and gonorrhea infection in women.
Top-line data from the study, EVOGUARD, is expected in October 2022. If outcomes are positive, Evofem will be able to submit regulatory applications in the first half of 2023 to the US Food and Drug Administration (FDA) to expand EVO100 indication beyond prevention of pregnancy to include prevention of urogenital chlamydia and gonorrhea infection in women.
"This is a major milestone for Evofem and brings us closer to our goal of providing women a safe and effective, woman-controlled prophylactic measure against chlamydia and gonorrhea, the two most commonly reported sexually transmitted infections in the US," said Saundra Pelletier, chief executive officer of Evofem Biosciences, in a press release.
Evofem Biosciences focuses on women’s sexual and reproductive health, and EVO100 was the company’s first FDA-approved product. EVO100 was the first nonhormonal contraceptive gel designed to maintain vaginal pH within the normal range of 3.5-4.5, an acidic environment that is inhospitable to sperm. It comes in a pre-filled dose applicator administered vaginally immediately before (or up to 1 hour before) every act of intercourse.
According to Evofem, the EVOGUARD trial builds on the positive findings from AMPREVENCE, a randomized, double-blind, placebo-controlled phase 2b/3 clinical trial published in the August 2021 issue of the American Journal of Obstetrics and Gynecology. Results showed that EVO100 significantly reduced the risk of chlamydia and gonorrhea infections in women who were at high risk for both sexually transmitted infections and was generally safe and well-tolerated.
Approximately 1730 women who had a chlamydia or gonorrhea infection in the previous 4 months were recruited for EVOGUARD at approximately 90 sites in the US for a 4-month interventional period, followed by a 1-month follow-up period.
The FDA has granted Fast Track designation and Qualified Infectious Disease Product designation to EVO100 for the prevention of chlamydia and gonorrhea infections in women. If approved, EVO100 would be the first prescription product to receive FDA approval for the prevention of chlamydia and gonorrhea infection.