[Ip-health] Entasis Therapeutics & the Global Antibiotic Research & Development Partnership to Develop a New Treatment for Drug-Resistant Gonorrhea
beyerp at who.int
Sun Jul 9 12:05:23 PDT 2017
Entasis Therapeutics and the Global Antibiotic Research & Development Partnership (GARDP) to Develop a New Treatment for Drug-Resistant Gonorrhea
First partnering deal for newly-created GARDP with Entasis includes access and stewardship strategy to tackle drug-resistant gonorrhea
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) that was created by WHO and DNDi and Entasis Therapeutics. The announcement comes as the World Health Organization (WHO) releases alarming new data today showing that of 77 countries surveyed across the world, more than 60% report resistance to the last-resort treatment for gonorrhea.
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.
If zoliflodacin receives regulatory approval, Entasis will grant GARDP an exclusive license with sublicensing rights for manufacturing worldwide and for the sale and/or distribution in 168 countries or territories. Both GARDP and Entasis are committed to affordable and equitable pricing in their respective territories.
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.
For more information see: https://www.gardp.org/2017/news-resources/press-releases/entasis-therapeutics-and-gardp-to-develop-new-treatment-for-drug-resistant-gonorrhea/
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