Evofem Biosciences, Inc. (NASDAQ: EVFM) is a clinical-stage biopharmaceutical company committed to developing and commercializing innovative products to address unmet needs in women's sexual and reproductive health. The Company aims to advance the lives of women by developing innovative solutions, such as woman-controlled contraception and potential protection from certain sexually transmitted infections (STIs).
The Company’s lead investigational product candidate is an investigational Multipurpose Vaginal pH Regulator (MVP-R™) named Phexxi™ (L-lactic acid, citric acid, potassium bitartrate) Vaginal Gel 1.8%/1%/0.4%.
Phexxi is designed to regulate vaginal pH within the normal range of 3.5 to 4.5, even in the presence of semen, which normally raises the vaginal pH to 7.0 to 8.0. This maintains an acidic environment that is inhospitable to sperm and certain viral and bacterial pathogens associated with sexually transmitted infections, but is integral to the survival of healthy bacteria in the vagina.
Phexxi is currently being reviewed by the U.S. Food and Drug Administration (FDA) for prevention of pregnancy and has been assigned a Prescription Drug User Fee Act (PDUFA) goal date of May 25, 2020.
The Company’s investigational MVP-R candidate, EVO100, is being evaluated for prevention of urogenital transmission of both Chlamydia trachomatis infection (chlamydia) and Neisseria gonorrhoeae infection (gonorrhea) in women.
According to the U.S. Centers for Disease Control and Prevention (CDC), rates of infection for chlamyida and gonorrhea climbed in 2018 for the fifth consecutive year in the United States. Nearly 2.4 million domestic cases of these sexually transmitted infections (STIs) were diagnosed in 2018, with 1.8 million newly reported chlamydia cases and nearly 600,000 newly reported gonorrhea cases.1 The CDC also reported that gonorrhea is increasingly becoming antibiotic resistant, making it much harder, or sometimes impossible, to treat.2
In December 2019, Evofem reported positive, statistically significant top-line data from a double-blind placebo-controlled Phase 2b clinical trial (AMPREVENCE) evaluating EVO100 to prevent urogenital acquisition of certain sexually transmitted infections in women. This landmark study met its primary and secondary endpoints, demonstrating a 50% relative risk reduction in chlamydia infection and a 78% relative risk reduction in gonorrhea infection compared to placebo.