Evofem Biosciences Inc (NASDAQ:EVFM) recently announced the dosing of the first patient in its phase 3 clinical trial to evaluate its preventative therapy for chlamydia and gonorrhea
The announcement about dosing the first patient in the phase 3 clinical trial of EVO100 represents a significant milestone for the company as far as the therapy’s development is concerned. The phase 3 clinical trial will evaluate EVO100’s safety and efficacy as a potential preventative therapy for gonorrhea and chlamydia in women.
“We are thrilled to initiate the EVOGUARD trial to further evaluate EVO100 for prevention of chlamydia and gonorrhea infection in women, for which there are currently no prescription products available,” stated Evofem’s Chief Medical Officer, Dr. Kelly Culwell.
EVO100’s development is vital especially with the rising cases of gonorrhea and chlamydia infections
Dr. Culwell also stated that the company will continue to focus on creating unique therapies that it will use to target the unmet medical needs of women. Neisseria gonorrhea and Chlamydia trachomatis infection rates registered consistent increases from 2014 to 2018. According to global estimates, roughly 95 million women are at risk of contracting gonorrhea and chlamydia by 2025. Gonorrhea in particular has become more resistant to existing medicines.
Dr. Culwell stated that the two diseases have become more prevalent and the difficulty in treating them and combined with the drug resistance highlights the urgency for preventative treatments such as EVO100. The EVOGUARD clinical trial will be conducted as a placebo-controlled, double-blind trial to determine the safety and efficacy of EVO100.
The clinical trial will enroll 1,730 participants that have been diagnosed with gonorrhea and chlamydia infections at least 16 weeks prior to enrolling in the study. The participants will be randomized such that some will receive EVO100 as a vaginal gel and some of the other patients will receive a placebo. The study will run for 16 weeks.
The developmental treatment yielded positive findings in previous studies. It was even awarded fast-track designation by the FDA as a preventative treatment for chlamydia. It also earned a Qualified Infectious Disease Product (QIDP) status for preventing gonorrhea in women.