The Global Antibiotic Research and Development Partnership (GARDP) and the Department of Disease Control of the Thailand Ministry of Public Health (Thai DDC) have signed a Memorandum of Understanding (MOU) to explore opportunities to improve gonorrhoea treatment in Thailand, with the intention to develop an access and stewardship strategy to ensure future antibiotics will be available as early as possible in the country.
GARDP is working with US-based biotech Entasis Therapeutics on the phase 3 clinical trial of zoliflodacin, a novel, first-in-class treatment active against resistant strains of gonorrhoea. This trial is currently ongoing in four countries, including Thailand. Under its partnership agreement with Entasis Therapeutics, GARDP is responsible for key clinical and pharmaceutical development activities to support regulatory approval, market access and availability of zoliflodacin, mainly in low- and middle-income countries.
The collaboration between GARDP and Thai DDC will consider how to support a regulatory submission pathway and post registration strategy to ensure the availability of zoliflodacin. The parties will also seek to further define the burden of gonorrhoea in Thailand, including conducting prevalence studies with the World Health Organization, as well as exploring post approval evidence generation activities to support the effective and appropriate use of zoliflodacin in the country.
“This collaboration with Thailand’s Ministry of Public Health is an important step in further understanding the burden of gonorrhoea and ensuring a public health treatment is responsibly and sustainably available to priority populations,“ said Seamus O’Brien, GARDP Director of Research and Development.
Dr. Rossaphorn Kittiyaowamarn, Chief of Bangrak STIs Center, Department of Disease Control, Ministry of Public Health, said: “This collaboration represents a critical opportunity to further define the burden of gonorrhoea in Thailand, while shifting from symptomatic to diagnostic treatment of this disease. At the Department of Disease Control, we believe partnerships are key to addressing the growing challenge of drug-resistant gonorrhoea, which is why we look forward to collaborating with GARDP on an access and stewardship strategy for this new gonorrhoea treatment.”
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.
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. www.gardp.org