Entasis and GARDP to evaluate zoliflodacin in Phase III trial for drug-resistant gonorrhea


US-based Entasis Therapeutics and the not-for-profit Global Antibiotic Research & Development Partnership (GARDP) have entered a partnership to develop a new treatment for drug-resistant gonorrhea.

As part of the deal, zoliflodacin, a new first-in-class oral antibiotic and one of the only treatments being developed to address the rapidly growing threat of drug-resistant gonorrhea, will be evaluated in a global Phase III clinical trial.

The move follows data presented by the World Health Organisation (WHO), which showed that out of 77 countries surveyed worldwide, more than 60% report resistance to the last-resort treatment for gonorrhea.

The trial is sponsored by GARDP / Drugs for Neglected Diseases (DNDi) initiative and will be carried out in countries such as South Africa, the US and Thailand.

As part of the development programme, the US National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institutes of Health (NIH), intends to support the drug's pharmacological studies.

In parallel with the Phase III trial, 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 gonorrhea.

According to Entasis, if zoliflodacin receives regulatory approval, the company will grant an exclusive licence to GARDP with sublicensing rights in most low-income and middle-income countries, while retaining commercial rights in high-income markets.

"This partnership with Entasis aims to make sure we are ready as the last resort treatments for gonorrhea fail, so that the nightmare scenario of untreatable gonorrhea does not become a reality."

Both parties are committed to affordable and equitable pricing in their respective territories.

GARDP director Manica Balasegaram said: "Gonorrhea has progressively developed resistance to the drugs prescribed to treat it, becoming resistant to all but last resort treatments.

"This partnership with Entasis aims to make sure we are ready as the last resort treatments for gonorrhea fail, so that the nightmare scenario of untreatable gonorrhea does not become a reality.

"Since any new antibiotic must be effectively 'stewarded' and accessible to all who need it, we will conduct the additional studies needed not just for registration of zoliflodacin, but to have maximum public health impact – a global approach to a global challenge."

The data released by WHO shows resistance to these treatments, with the danger they could join the long list of antibiotics that have become ineffective against gonorrhea over past decades.

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

The US Food and Drug Administration (FDA) has already provided qualified infectious disease product (QIDP) designation and fast-track status to zoliflodacin.