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Entasis, GARP to start phase 3 trials of drug-resistant gonorrhea antibiotic

PBR Staff Writer Published 07 July 2017

Entasis Therapeutics and Global Antibiotic Research and Development Partnership (GARDP) will initiate pivotal trials of oral antibiotic zoliflodacin (ETX0914) being developed to treat drug-resistant gonorrhea.

The partners will jointly advance zoliflodacin in a phase 3 trials that will be done in countries like South Africa, the US, and Thailand.

Zoliflodacin’s pharmacological studies are likely to be supported by the US National Institute of Allergy and Infectious Diseases (NIAID) as part of the development programme.

In addition with the phase 3 trial sponsored by GARDP/DNDi (Drugs for Neglected Diseases initiative), GARP will work alongside the scientists at Entasis to undertake non-clinical activities like microbiology surveys. This, according to the partners will make sure that zoliflodacin is effective against recent and geographically diverse gonorrhea strains.

GARDP director Manica Balasegaram said: “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.”

As per the agreement, Entasis will award exclusive license with sublicensing rights for zoliflodacin to GARDP in most of the low- and middle-income countries if the drug secures regulatory approval. The pharma company will retain commercial rights of the gonorrhea drug in high-income markets.

Entasis Therapeutics CEO Manos Perros said: “Zoliflodacin has the potential to stem the spread of drug-resistant gonorrhea by providing a convenient oral cure for patients and their partners.

“Our collaboration with GARDP demonstrates our commitment to addressing high unmet medical needs through novel antibacterials, while ensuring responsible use and access to our medicines for all patients.”

In a recent phase 2 trial, zoliflodacin after a single oral dose was shown to be potent in vitro activity against Neisseria gonorrhea while also achieving promising efficacy.

The US Food and Drug Administration had designated zoliflodacin as a Qualified Infectious Disease Product (QIDP) and had also given it the Fast Track status in June 2014.