New treatment for drug-resistant gonorrhea to enter phase 3 development

Zoliflodacin, a first-in-class oral antibiotic and one of the few treatments in development for drug-resistant gonorrhea, will be assessed during an international phase 3 trial, according to a press release.

The announcement follows the release of new WHO data that shows more than 60% of 77 countries surveyed are reporting drug-resistant gonorrhea infections.

Entasis Therapeutics and the Global Antibiotic Research and Development Partnership (GARDA) will co-develop zoliflodacin, which is the only treatment candidate designed specifically for gonorrhea, the release said. The drug previously demonstrated in vitro activity against Neisseria gonorrhea isolates resistant to fluoroquinolones and extended-spectrum cephalosporins in a phase 2 trial, achieving efficacy after a single oral dose.

The phase 3 trial, sponsored by GARDP and the Drugs for Neglected Diseases Initiative, will be carried out in countries including South Africa, the United States and Thailand. As part of the development program, the National Institute of Allergy and Infectious Diseases plans to support pharmacological studies on the drug. In addition, GARDP will work with Entasis researchers during nonclinical activities, including microbiology surveys, to ensure that it is effective against geographically diverse gonorrhea strains.

Zoliflodacin is one of just three candidate drugs for the treatment of gonorrhea in the pipeline.

The FDA previously designated zoliflodacin as a Qualified Infectious Disease Product and awarded the drug Fast Track status. If approved, Entasis will grant GARDP with an exclusive license and sublicensing rights for zoliflodacin in most low-and middle-income countries, according to the release. The company will retain commercial rights in high-income markets.

“Gonorrhea has progressively developed resistance to the drugs prescribed to treat it, becoming resistant to all but last resort treatments,” Manica Balasegaram, MD, director of the Global Antibiotic Research and Development Partnership (GARDP), said in the release. “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.”

Disclosure: Balasegaram is director of GARDP.

Zoliflodacin, a first-in-class oral antibiotic and one of the few treatments in development for drug-resistant gonorrhea, will be assessed during an international phase 3 trial, according to a press release.

The announcement follows the release of new WHO data that shows more than 60% of 77 countries surveyed are reporting drug-resistant gonorrhea infections.

Entasis Therapeutics and the Global Antibiotic Research and Development Partnership (GARDA) will co-develop zoliflodacin, which is the only treatment candidate designed specifically for gonorrhea, the release said. The drug previously demonstrated in vitro activity against Neisseria gonorrhea isolates resistant to fluoroquinolones and extended-spectrum cephalosporins in a phase 2 trial, achieving efficacy after a single oral dose.

The phase 3 trial, sponsored by GARDP and the Drugs for Neglected Diseases Initiative, will be carried out in countries including South Africa, the United States and Thailand. As part of the development program, the National Institute of Allergy and Infectious Diseases plans to support pharmacological studies on the drug. In addition, GARDP will work with Entasis researchers during nonclinical activities, including microbiology surveys, to ensure that it is effective against geographically diverse gonorrhea strains.

Zoliflodacin is one of just three candidate drugs for the treatment of gonorrhea in the pipeline.

The FDA previously designated zoliflodacin as a Qualified Infectious Disease Product and awarded the drug Fast Track status. If approved, Entasis will grant GARDP with an exclusive license and sublicensing rights for zoliflodacin in most low-and middle-income countries, according to the release. The company will retain commercial rights in high-income markets.

“Gonorrhea has progressively developed resistance to the drugs prescribed to treat it, becoming resistant to all but last resort treatments,” Manica Balasegaram, MD, director of the Global Antibiotic Research and Development Partnership (GARDP), said in the release. “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.”

Disclosure: Balasegaram is director of GARDP.