The Global Antibiotic Research and Development Partnership (GARDP), a not-for-profit developing new treatments for drug resistant infections, and Entasis Therapeutics (NASDAQ: ETTX), a clinical-stage biopharmaceutical company focused on the discovery and development of novel antibacterial products, announced today the activation of the first site in Thailand as part of a global phase 3 clinical study of zoliflodacin for the treatment of gonorrhoea.
As a novel, first-in-class oral treatment, zoliflodacin is active against resistant clinical strains of gonorrhoea and has the potential for significant benefits compared to the current standard of care of intramuscular injections. GARDP is partnering with Entasis Therapeutics to complete late-stage development, with GARDP fully funding and sponsoring the global phase 3 clinical study.
“The activation of the study in Thailand, a pivotal country in our global study of zoliflodacin, is an important milestone in our efforts to make available a new public health focussed treatment for gonorrhoea,” said Seamus O’Brien, Research and Development Director of GARDP. “The multicountry nature of the study reflects our commitment to ensuring this drug is available to those priority populations who need it.”
Three sites, all in Bangkok, are taking part in the Thai study – the Silom Community Clinic, the Institute of HIV Research and Innovation Foundation (IHRI), and the Bangrak STIs Center.
“A Neisseria gonorrhoeae infection is particularly insidious as it often lacks symptoms. However, if left untreated, gonorrhea can have serious and permanent consequences, including infertility, ectopic pregnancies, and an increased risk for acquiring HIV,” said Dr Joseph Woodring, Principal Investigator for the trial based at Bangkok’s Silom Community Clinic and Senior Medical Officer for the Centers for Disease Control and Prevention.
“This trial is an opportunity to address this public health challenge that particularly affects at-risk groups that our clinic serves – namely, men who have sex with men and transgender women. This trial also recognizes the strong health research infrastructure role that Thailand can play in developing urgently needed treatments,” said Dr Woodring.
Dr Rossaphorn Kittiyaowamarn, Principal Investigator for Thailand’s Ministry of Public Health sites, said: “Thailand is an emerging leader for clinical trials thanks to national policies supporting research activities, its universal healthcare system, highly skilled research workforce and access to world-class medical equipment and facilities. Data shows a high prevalence of gonorrhoea in Thailand, and this study is an important opportunity to test safety and effectiveness of a new antibiotic, zoliflodacin, for an infection that has progressively developed resistance to available treatments.”
The clinical study is expected to enrol approximately 1000 adults with urogenital gonorrhoea from sites in the United States, Netherlands, South Africa and Thailand. Patients included in the trial will be randomized to receive either zoliflodacin or a combination of ceftriaxone and azithromycin and will be assessed one week later for persistence of the infection.
Gonorrhoea is the most common bacterial STI in Thailand, affecting both men and women, particularly between 15 and 24 years old. In Thailand and globally the infection rate of gonorrhoea is increasing, with 87 million new cases estimated each year worldwide. Gonorrhoea is caused by the bacterium Neisseria gonorrhoeae, which has progressively developed resistance to globally recommended treatments and has been identified by the World Health Organization as among a family of ‘priority pathogens’ posing the greatest threat to global health.
Learn more about GARDP’s STI Programme here >
The Global Antibiotic Research and Development Partnership (GARDP) is a Swiss not-for-profit organization developing new treatments for drug-resistant infections that pose the greatest threat to health. GARDP was created by the World Health Organization (WHO) and the Drugs for Neglected Diseases initiative (DNDi) in 2016 to ensure that everyone who needs antibiotics receives effective and affordable treatment. We aim to develop five new treatments by 2025 to fight drug-resistant infections. GARDP is funded by the governments of Germany, Japan, Luxembourg, Monaco, Netherlands, South Africa, Switzerland, United Kingdom, as well as Médecins Sans Frontières and private foundations. GARDP is registered under the legal name GARDP Foundation.
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