Investigational antibiotic shows high cure rates in gonorrhoea at Phase 2
pharmafile | November 8, 2018 | News story | Research and Development | National Institute of Allergy and Infectious Diseases, National Institutes of Health, gonorrhoea, pharma, zoliflodacin
A Phase 2 study sponsored by The National Institute of Allergy and Infectious Diseases (NIAID), a branch of the National Institutes of Health, has demonstrated that Entasis Therapeutics’ investigational oral antibiotic zoliflodacin successfully cured most participants’ cases of uncomplicated gonorrhoea.
As part of the study, a team of researchers at the Louisiana State University Health Sciences Center recruited 179 participants from sexual health clinics in New Orleans, Indianapolis, Birmingham and Durham; 167 were male and 12 were non-pregnant females, all between the ages of 18 and 55 and with symptoms of uncomplicated urogenital gonorrhoea, untreated urogenital gonorrhoea or sexual contact with someone with the condition within two weeks of enrolment.
The common sexually transmitted infection affected around 550,000 in the US throughout 2017.
It was found that, of the 117 per-protocol participants who were evaluated six days after treatment, 98% of those receiving 2g of zoliflodacin and 100% of those receiving 3g were cured of urogenital gonorrhoea, as well as 100% of those receiving a 500mg dose of injectable ceftriaxone, according to culture results.
Additionally, all ten patients receiving the 2g or 3g dose saw their rectal gonorrhoea cured, as did all 3 receiving ceftriaxone, but only 4 of 6 and 7 of 9 of those receiving 2g or 3g dose saw their pharyngeal form of the condition cured, while all four of those receiving ceftriaxone did.
“The rate of reported gonorrhoea cases in the United States has increased 75% since the historic low in 2009, and antibiotic resistance has considerably reduced the number of treatment options for this disease,” explained NIAID Director Dr Anthony S Fauci. “These encouraging research findings published today suggest that zoliflodacin has the potential to be a useful and easy-to-administer oral antibiotic for treating gonorrhoea.”
Zoliflodacin has secured FDA fast track status, with a Phase 3 trial of the drug scheduled to begin next year.
Matt Fellows
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