The Food and Drug Administration (FDA) has granted Fast Track designation to EVO100 for the prevention of urogenital gonorrhea in women.
EVO100 is pH-modulating vaginal gel designed to reduce certain vaginal infections by balancing vaginal pH, thereby maintaining healthy vaginal flora. The designation is supported by data from the double-blind, placebo-controlled phase 2b/3 AMPREVENCE trial (ClinicalTrials.gov: NCT03107377), which assessed the efficacy and safety of EVO100 in reducing the risk of gonorrhea and chlamydia infections in 860 women.
Patients were randomly assigned 1:1 to receive EVO100 (n=426) or placebo (n=434) intravaginally at least 1 hour prior to vaginal intercourse. Results showed that EVO100 met the primary and secondary endpoints with statistically significant reductions in the risk of chlamydia and gonorrhea, respectively.
The chlamydia infection rate for the EVO100 arm was 4.8% (n=14/289) compared with 9.7% (n=28/290) for placebo (P =.0256), indicating a relative risk reduction of 50%. The gonorrhea infection rate for the EVO100 arm was 0.7% (n=2/280) compared with 3.2% (n=9/277) for placebo (P =.0316), representing a relative risk reduction of 78%. The most common adverse events reported with EVO100 were vulvovaginal candidiasis (5.1%), vaginal discharge (3.2%), and urinary tract infection (3.2%).
The Company is currently enrolling women in the phase 3 EVOGUARD trial (ClinicalTrials.gov: NCT04553068) to assess the efficacy and safety of EVO100 in the prevention of chlamydia and gonorrhea. Study enrollment is expected to be completed by the end of 2021 and topline study data is expected by mid-2022.
- Evofem Biosciences receives Fast Track designation for EVO100 for prevention of gonorrhea in women. [press release]. San Diego, CA: Evofem Biosciences, Inc.; May 12, 2021.
- Evofem Biosciences announces publication in American Journal of Obstetrics and Gynecology of AMPREVENCE study of EVO100 for chlamydia and gonorrhea prevention. [press release]. San Diego, CA: Evofem Biosciences, Inc.; March 16, 2021.