On Friday, the World Health Organization (WHO) released alarming new data showing that of 77 countries surveyed across the world, more than 60% report resistance to the last-resort treatment for gonorrhea.
On the same day, Entasis Therapeutics announced that Zoliflodacin, a novel first-in-class oral antibiotic and one of the only treatments in development to address the rapidly-growing threat of drug-resistant gonorrhea will enter pivotal trials, thanks to a new partnership between the not-for-profit Global Antibiotic Research and Development Partnership (GARDP) and Entasis.
Entasis and GARDP will co-develop the first-in-class antibiotic, zoliflodacin, in a global Phase 3 clinical trial to be carried out in countries including South Africa, the United States of America, and Thailand.
“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,” said Manica Balasegaram, M.D., GARDP director. “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.”
There are about 78 million new cases of gonorrhea every year. The Neisseria gonorrhoeae 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.
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“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,” said Manos Perros, Ph.D., CEO of Entasis Therapeutics. “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.”
Entasis’ zoliflodacin is the first in a new class of antibiotics and the only new clinical candidate developed specifically to treat gonorrhea, which is important for stewardship. Zoliflodacin demonstrated potent in vitro activity against Neisseria gonorrhoeae, including isolates resistant to fluoroquinolones and extended spectrum cephalosporins, achieving promising efficacy after a single oral dose in a recent Phase 2 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.
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