Evofem Biosciences is dedicated to developing and commercializing innovative products to address unmet needs in women’s sexual and reproductive health. Evofem is leveraging its proprietary vaginal pH modulator to develop potential new indications and products for multiple indications, including the prevention of urogenital transmission of chlamydia and gonorrhea in women, recurrent bacterial vaginosis, and an MPT vaginal gel targeting HIV prevention.
Phexxi for the prevention of urogenital chlamydia and urogenital gonorrhea in women
EVO100 (the investigational name for Phexxi) is in development for two potential new indications, the prevention of urogenital chlamydia and urogenital gonorrhea in women, leveraging its vaginal pH modulator mechanism of action. Infection with these bacterial pathogens has been associated with a higher vaginal pH level. By maintaining a normal vaginal pH and working to keep vaginal pH in the 3.5-4.5 range, Phexxi creates an environment that is detrimental to their growth and proliferation.
In March 2022, Evofem completed enrollment in EVOGUARD, the confirmatory Phase 3 clinical trial to evaluate the safety and efficacy of Phexxi for the prevention of urogenital Chlamydia trachomatis and Neisseria gonorrhoeae infection in women. Top-line results are expected in the second half of 2022.
EVOGUARD builds on the positive, statistically significant outcomes of the Phase 2b AMPREVENCE study evaluating EVO100 for the prevention of chlamydia and gonorrhea. AMPREVENCE met its primary and secondary endpoints, and the study showed that EVO100 was generally safe and well-tolerated 1. Results of this double-blinded, placebo-controlled trial were presented at the 2020 STD Prevention Virtual Conference (view poster) and published in March 2021 in the American Journal of Obstetrics and Gynecology.
EVO100 has been granted Fast Track Designation for the prevention of chlamydia in women and the prevention of gonorrhea in women and is designated a Qualified Infectious Disease Product (QIDP) for both indications by the U.S. Food and Drug Administration23 .
EVO200 for the prevention of recurrent Bacterial Vaginosis (BV)
EVO200 is an investigational vaginal pH modulator in development for the prevention of recurrent Bacterial Vaginosis (BV). In a Phase 1 dose-finding trial for this indication, the highest dose formulation of the study drug demonstrated reduced vaginal pH for up to seven days following a single administration.
EVO200 has been designated a QIDP by the FDA for this indication.
MPT vaginal gel
We are collaborating with Orion Biotechnology to evaluate the compatibility and stability of Orion’s novel CCR5 antagonist, OB-002, in Phexxi with the goal of developing a Multipurpose Prevention Technology (MPT) product candidate for indications including the prevention of human immunodeficiency virus (HIV) in women. This collaboration will focus on determining compatibility and stability of OB-002 in Phexxi and is expected to yield results in the third quarter of 2022. Assuming positive results, the Company and Orion will seek government and philanthropic funding for subsequent clinical trials of the MPT vaginal gel product candidate.
These products have not been approved for marketing by the U.S. Food and Drug Administration or any other regulatory agency.