Evofem Biosciences Inc. (NASDAQ:EVFM) has announced that its third phase pivotal EVO100 trial, ‘EVOGUARD’ for chlamydia and gonorrhea prevention, is firmly on schedule. The company commenced EVOGUARD and enrolled the first patient in October 2020, and met study enrolment targets in October and November.
Evofem to enroll 1,730 subjects in the trial
Kelly Culwell, the company’s chief medical officer, said that inbound interest has been massive, especially from women and study centers. There are more than double the number of sites requested to take part in the clinical trial. Culwell said that around one-third of the study centers involved will be operational by the end of 2020. Interestingly the company plans to activate the rest of the sites in 2021, with enrolment in the 1,730 trial expected by the end of 2021.
The rates of chlamydia trachomatis and Neisseria gonorrhea infections have been on the rise despite the CDC recommending people to use condoms to avoid infections. Normally most cases are not reported since people infected with chlamydia are asymptomatic and rarely seek testing.
Gonorrhea and Chlamydia infections still high
The principal investigator of the study, Valerie Sorkin-Wells, said that any sexually active individual can get gonorrhea or chlamydia. She added that even though there are preventive measures in place, such as condoms, cases of STI infections continue to rise. Valerie said that if the EVOGUARD trial results validate the statistically AMPREVENC study results, the EVO100 will be an important novel way of preventing gonorrhea and chlamydia in women.
EVO100 is an experimental vaginal gel that EvoFem has designed to regulate vaginal PH within the normal acidic range. The company previously evaluated the EVO100 in a double-blind, placebo-controlled Phase 2b study, AMPREVENCE, in 860 women across the US. The study met the primary and secondary endpoints, and there was a statistically significant reduction in gonorrhea and chlamydia infection rates compared to the placebo. Most importantly, there was a reduction of risk by 50% in chlamydia infection and around 78% reduction in gonorrhea infection after 16 weeks of EVO100 administration relative to the placebo.