Gonorrhoea diagnostics for drug stewardship

What is this project?

This project will define, develop and assess feasibility of potential companion diagnostics for new gonorrhoea drugs, in order to guide appropriate treatment and potentially delay the development of antibiotic resistance (AMR) to these therapies.

Why are we working on it?

Gonorrhoea is one of the most common sexually transmitted infections in the world. N. gonorrhoeae, the bacterium that causes the disease, is evolving into a superbug that has already defeated penicillin, spectinomycin, tetracycline, ceftriaxone and azithromycin. It may soon become untreatable. As is the case for AMR in general, the burden of this public health threat is currently falling most heavily on low- and middle-income countries, although it is becoming a global challenge as drug-resistant strains of gonorrhoea have started to emerge in several countries.

New drugs to fight so-called “super-gonorrhoea” are needed urgently – but we already know that sooner or later the bacteria will develop resistance to them. Companion diagnostics, designed to protect new antibiotics for as long as possible, are therefore as essential as the drugs themselves.

What does it involve?

One of the most advanced potential new gonorrhoea drugs on the horizon, zoliflodacin, is being developed by GARDP; CARB-X is also supporting development of novel drug compounds. We are aiming to ensure that new diagnostics are ready to be introduced ahead of the introduction of these new antibiotics, by prioritizing three workstreams.

• Redefining the current clinical algorithm to ensure stewardship of new drugs: a diagnostic-guided algorithm will ensure that new gonorrhoea drugs can be reserved for use only in the patients who need them.
• Development and feasibility assessment of new diagnostics: diagnostics that meet defined target product profiles will be supported through rapid development and feasibility assessment.
• Preparing for scale: a clear roadmap will be developed to support regulatory approvals and implementation of promising technologies.

What do we expect to achieve?

This project aims to ensure that companion diagnostics are available to support delivery and roll-out of new gonorrhoea drugs so that their efficacy can be protected for as long as possible.

Partners and funding

To develop companion diagnostics for zoliflodacin, we are collaborating with the WHO Department of Reproductive Health and Research (RHR) and the Global Antibiotic Research & Development Partnership (GARDP).

These activities are supported by the Global Antimicrobial Resistance Innovation Fund (GAMRIF), a UK aid programme.