Zoliflodacin, a new oral antibiotic and one of the only treatments in development to address the rapidly-growing threat of drug-resistant gonorrhoea will enter pivotal trials soon. The drug is being developed in partnership between the not-for-profit Global Antibiotic Research and Development Partnership (GARDP) and Entasis Therapeutics. The announcement comes as the World Health Organization (WHO) released an alarming new data showing that of 77 countries surveyed across the world, more than 60% report resistance to the last-resort treatment for gonorrhoea.

Entasis and GARDP will co-develop the first-in-class antibiotic, zoliflodacin, in a global Phase III clinical trial to be carried out in countries including South Africa, the United States of America, and Thailand. The US National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), plans to support pharmacological studies on the drug as part of the development programme.

In parallel with the Phase III trial, which is sponsored by GARDP/DNDi (Drugs for Neglected Diseases initiative), GARDP will work with Entasis scientists to carry out non-clinical activities  including microbiology surveys to ensure that the product is effective against recent and geographically diverse strains of gonorrhoea. If zoliflodacin receives regulatory approval, Entasis will grant GARDP an exclusive license with sublicensing rights in most low- and middle-income countries, while retaining commercial rights in high-income markets. Both GARDP and Entasis are committed to affordable and equitable pricing in their respective territories, a joint statement issued by the collaborators has said..

There are about 78 million new cases of gonorrhoea every year. The Neisseria gonorrhoea pathogen creates a potentially serious infection in the genitals, rectum, and throat and can result in infertility, ectopic pregnancy, increased risk of HIV, and pelvic inflammatory disease amongst others. Currently, the main recommended treatment is an injection of ceftriaxone and an oral dose of azithromycin.

“Antibiotic resistance is a serious public health issue, driving an unmet need within many communities around the world. Gonorrhoea causes significant harm to patients who suffer from it, as well as accelerating the spread of other sexually transmitted infections,ÂÂ said Dr Manos Perros, CEO of Entasis Therapeutics.

Entasis zoliflodacin is the first in a new class of antibiotics and the only new clinical candidate developed specifically to treat gonorrhoea, which is important for stewardship. Zoliflodacin demonstrated potent in vitro activity against Neisseria gonorrhoea, including isolates resistant to fluoroquinolones and extended spectrum cephalosporins, achieving promising efficacy after a single oral dose in a recent Phase II clinical study sponsored by NIAID. Zoliflodacin has been designated a Qualified Infectious Disease Product (QIDP) by the US Food and Drug Administration and awarded Fast Track status.

Antimicrobial resistance is recognized as a global crisis by the WHO and the G20, with calls for new mechanisms to develop new treatments. In June, the G20 held the first ever Health Ministers meeting which called for “broadening the voluntary financial support for initiatives, including GARDP, which reinvigorate research and development in science and research for antimicrobials.ÂÂ

Launched in May 2016 by the World Health Organization (WHO) and the Drugs for Neglected Diseases initiative (DNDi), GARDP aims to develop and deliver new treatments for bacterial infections where drug resistance is present or emerging, or for which inadequate treatment exists. Zoliflodacin is one of GARDPÂs first research and development projects and its first licensing deal with a company. GARDP is currently operating within DNDi, which provides GARDPÂs governance.  Entasis Therapeutics is developing a portfolio of innovative cures for serious drug-resistant bacterial infections, a global health crisis affecting the lives of millions of patients.