Evofem Biosciences Provides Update on Pivotal Phase 3 Trial of EVO100 for Prevention of Chlamydia and Gonorrhea
SAN DIEGO, Dec. 17, 2020 /PRNewswire/ -- Evofem Biosciences Inc., (NASDAQ: EVFM) today announced that its pivotal Phase 3 trial, 'EVOGUARD,' of EVO100 for the prevention of chlamydia and gonorrhea remains firmly on schedule. EVOGUARD was initiated and the first patient was enrolled in October 2020, and study enrollment targets were met in both October and November 2020 despite the ongoing COVID-19 pandemic.
"Inbound interest has been exceptionally high from women and study centers alike, with more than double the number of planned sites requesting to participate in this important clinical trial," said Kelly Culwell, MD, Chief Medical Officer of Evofem Biosciences. "Approximately one-third of participating study centers will be up and running by year-end 2020. We will activate all remaining sites in 2021, and expect to complete enrollment of this 1,730-patient trial by year-end 2021."
Despite the CDC recommendation for condom use to prevent sexually transmitted infections (STIs), rates of infection with Chlamydia trachomatis and Neisseria gonorrhea climbed in 2018 for the fifth consecutive year in the United States.1 A large number of cases are not reported because most people with chlamydia are asymptomatic and do not seek testing.
"Any sexually active person can be infected with chlamydia or gonorrhea, and despite current preventive measures, such as condoms, the number of reported cases of these STIs continues to rise," said Valerie Sorkin-Wells, M.D., FACOG, of the Arizona Wellness Center for Women and a Principal Investigator in the EVOGUARD clinical trial. "If the results of the ongoing EVOGUARD trial confirm the statistically significant AMPREVENCE trial results, EVO100 could be an important new method to prevent the transmission of chlamydia and gonorrhea in women."
EVO100 is an investigational vaginal gel designed to modulate vaginal pH in the normal acidic range. It was previously evaluated in a double-blinded, placebo-controlled Phase 2b trial, AMPREVENCE, conducted in 860 women at 50 U.S. study centers. This landmark study met its primary and secondary efficacy endpoints, with statistically significant reductions in chlamydia and gonorrhea infection rates in women receiving EVO100 versus placebo. There was a 50% reduction of risk in chlamydia infection and 78% reduction of risk in gonorrhea infection following 16 weeks of EVO100 use compared with placebo, and EVO100 was generally well tolerated with most side effects being mild to moderate. These positive and statistically significant outcomes were presented at the Virtual 2020 STD Prevention Conference in September 2020.
Chlamydia is the most frequently reported bacterial sexually transmitted infection in the United States2. It can cause cervicitis in women and urethritis and proctitis in both men and women, and chlamydial infections in women can lead to serious consequences including pelvic inflammatory disease (PID), tubal factor infertility, ectopic pregnancy, and chronic pelvic pain.
Gonorrhea, the second most frequently reported infectious disease in the United States, is increasingly becoming antibiotic resistant, making it much harder, or sometimes impossible, to treat.3
The California Department of Public Health has received increasing reports of disseminated gonococcal infections (DGI), an uncommon but severe complication of untreated gonorrhea4. DGI occurs when Neisseria gonorrhoeae invades the bloodstream and spreads to distant sites in the body, leading to clinical manifestations such as septic arthritis, polyarthralgia, tenosynovitis, petechial/pustular skin lesions, bacteremia, or, on rare occasions, endocarditis or meningitis.
EVO100 has been granted Fast Track Designation for the prevention of chlamydia in women by the FDA. The vaginal pH modulator is also an FDA-designated Qualified Infectious Disease Product (QIDP) for the prevention of gonorrhea in women. Under QIDP guidelines, EVO100 is eligible for certain incentives, including priority review associated with a New Drug Application (NDA) submission and a five-year extension of market exclusivity upon FDA approval for this indication.
EVOGUARD is funded in part by a strategic investment in Evofem by Adjuvant Capital, LLC.
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Company Codes: NASDAQ-NMS:EVFM