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, today announced the activation of the first site in South Africa as part of a global phase 3 trial of zoliflodacin for the treatment of gonorrhoea.
Zoliflodacin is a novel, first-in-class oral antibiotic being developed for the treatment of uncomplicated gonorrhoea. GARDP is partnering with Entasis Therapeutics to complete late-stage development, with GARDP fully-funding and sponsoring the global phase 3 trial.
“South Africa has one of the world’s highest burdens of sexually transmitted infections (STIs), including gonorrhoea, which is why GARDP is committed to working with Entasis to ensure this treatment is available in all places it is needed,” said Seamus O’Brien, Research and Development Director of GARDP. “This trial also recognizes the critical need to ensure treatments like zoliflodacin are relevant to populations in countries with a significant burden of disease.”
Edward Mukwaya, GARDP Clinical Trial Manager in South Africa, said South Africa’s research experience holds it in good stead. “South Africa is a major global hub for conducting clinical trials due to the robust health research infrastructure, with highly motivated, skilled and experienced researchers, state of the art research institutions and the availability of large patient numbers across therapeutic areas. Data shows we have a high prevalence of gonorrhoea in South Africa, and this study presents an opportunity to avail us with an additional treatment option.”
Three sites in South Africa are taking part in the study – the Wits Reproductive Health and HIV Institute (Wits RHI) based at the Hillbrow Health Precinct in Johannesburg, and two South African Medical Research Council (SAMRC) sites at Tongaat and Botha’s Hill in South Africa’s KwauZulu-Natal province.
“We are very encouraged to be involved in a trial that focuses on such a crucial public health challenge, said Sinead Delany-Moretlwe, the trial’s Principal Investigator in South Africa, based at the University of the Witwatersrand in Johannesburg. “If left untreated, gonorrhoea can have serious and permanent consequences, particularly for women, including infertility, life threatening ectopic pregnancies and pelvic inflammatory disease. We have the opportunity to work towards changing this trajectory.”
The Sexually Transmitted Infections Section Centre at the National Institute for Communicable Diseases will play a leading role in testing and collating microbiological samples from the South African study sites, for quality control and shipment to the central lab in the USA.
The trial is expected to enrol approximately 1,000 adults with urogenital gonorrhoea from clinical trial sites in the United States, Netherlands, Thailand and South Africa. Patients included in the trial will be randomized (2:1) 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 a common sexually transmitted infection (STI) affecting both men and women, particularly between 15 and 24 years old. Globally the infection rate of gonorrhoea is increasing, with 87 million new cases estimated each year. 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, no matter where they live. GARDP aims to develop five new treatments by 2025 to fight drug-resistant infections, focusing on sexually transmitted infections, sepsis in newborns and infections in hospitalized adults and children. 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