EVO100 – An investigational candidate for the prevention of urogenital chlamydia and gonorrhea in women
Our investigational drug candidate EVO100 vaginal gel is designed to reduce certain vaginal infections by:
- Balancing vaginal pH, thereby maintaining healthy vaginal flora and creating an environment that is detrimental to the growth and proliferation of harmful bacteria
- Using a different mechanism of action that may help to address drug resistance concerns
In October 2020, Evofem initiated EVOGUARD, a pivotal Phase 3 clinical trial to evaluate the safety and efficacy of EVO100 for the prevention of urogenital Chlamydia trachomatis and Neisseria gonorrhoeae infection in women. Top-line results are expected in 2022.
The Phase 2b AMPREVENCE study evaluating EVO100 for the prevention of chlamydia and gonorrhea 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).
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 the prevention of gonorrhea in women by the U.S. Food and Drug Administration2.
1 Chappell T et al. EVO100 Prevents Chlamydia and Gonorrhea in Women at High-Risk for Infection. Am. J. Obstet Gynecol, 2021. https://doi.org/10.1016/j.ajog.2021.03.005