Evofem Biosciences, Inc. (NASDAQ: EVFM) is a commercial-stage biopharmaceutical company committed to developing and commercializing innovative products to address unmet needs in women's sexual and reproductive health, including hormone-free, woman-controlled contraception and protection from certain sexually transmitted infections (STIs).
The Company’s first commercial product, Phexxi™ (lactic acid, citric acid and potassium bitartrate), is the first and only hormone-free, prescription vaginal gel approved in the United States for the prevention of pregnancy.
The Company is evaluating its investigational drug candidate EVO100 vaginal gel for the prevention of urogenital transmission of Chlamydia trachomatis infection (chlamydia) and Neisseria gonorrhoeae infection (gonorrhea) in women. In October 2020, Evofem initiated EVOGUARD, a pivotal Phase 3 clinical trial to evaluate the safety and efficacy of EVO100 for the prevention of chlamydia and gonorrhea infection in women. Top-line results are expected in 2022.
EVOGUARD builds on reported positive, statistically significant top-line data from a double-blind placebo-controlled Phase 2b clinical trial (AMPREVENCE). 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. AMPREVENCE results were presented at the 2020 STD Prevention Virtual Conference (view poster).
The Company has assembled a very strong management team with significant operational experience in the biopharmaceutical market. Specifically, our senior executives have a successful track record of developing and commercializing women’s health products including Mirena, Plan B One-Step, Yasmin, YAZ, NuvaRing, Paragard and Seasonique, among others.