The Global Antibiotic Research and Development Partnership (GARDP) and Entasis Therapeutics announced today the first patient in the Netherlands has been enrolled as part of a global phase 3 pivotal trial of zoliflodacin.
Zoliflodacin is a novel, first-in-class oral antibiotic being developed for the treatment of uncomplicated gonorrhoea. Following positive phase 2 results previously published in the New England Journal of Medicine (NEJM), Entasis and GARDP have partnered to complete late stage development, with GARDP fully-funding and sponsoring the global phase 3 trial.
The trial is expected to enrol approximately 1,000 adults with urogenital gonorrhoea from clinical trial sites in the United States (which launched in September 2019), Netherlands, Thailand and South Africa. Patients included in the trial will be randomized (2:1) to receive either zoliflodacin or a combination of ceftriaxone and azithromycin and will be assessed one week later for persistence of the infection. Data from the phase 3 clinical trial is anticipated in 2021.