Sexually Transmitted Infections (STIs) are worryingly on the increase, particularly among young people aged 15 to 24 years. Gonorrhoea is one of the most common STIs, with 87 million new infections worldwide every year. World Sexual Health Day on September 4 reminds us to highlight the critical need for prevention and treatment and to reflect on GARDP’s work towards a new and more effective and affordable treatment for gonorrhoea.
While gonorrhoea can infect anyone, it disproportionately impacts women. Left untreated, gonorrhoea can result in infertility, life threatening ectopic pregnancies and pelvic inflammatory disease. In pregnancy, gonorrhoea infection can lead to preterm delivery, small birth weight babies and even death. There is also the risk of transmitting the infection from a mother to her baby during childbirth.
For decades, gonorrhoea has progressively developed resistance to various antibiotics that were effective in its treatment. But there is renewed hope. GARDP is partnering with the biotech company Entasis Therapeutics, to develop a novel antibiotic called zoliflodacin. It’s the only drug being developed specifically to treat gonorrhoea. As a first-in-class treatment, zoliflodacin is active against resistant strains of gonorrhoea.
Following positive phase 2 clinical trial results, the drug is currently being evaluated in a global phase 3 trial. The United States, South Africa, Netherlands and Thailand will enroll around 1,000 volunteers with gonorrhoea to assess the effectiveness of zoliflodacin against standard treatments.
For the South Africa team, it’s a great opportunity to play a part in working towards a better outcome for people living with the often harsh consequences of the condition.
“Because of the high prevalence of gonorrhoea in South Africa, particularly in young women, South Africa is an ideal country in which to conduct this trial. South Africa also has a large population of people living with HIV. This is an important group to include in the study, as we also need to understand the efficacy and pharmacokinetics of zoliflodacin in people who are HIV positive,” says Jeanne Omony, a research doctor at one of the three South African study sites – the Wits Reproductive Health and HIV Institute (Wits RHI) in Hillbrow, Johannesburg and one of the investigators on the zoliflodacin study.
Edward Mukwaya, GARDP’s clinical trial manager, says South Africa’s research experience holds it in good stead.
“Among the countries with a high prevalence of gonorrhoea, South Africa also has a robust health research infrastructure, with highly qualified and experienced researchers as well as other amenities crucial to health research, such as well-equipped laboratories.”
The South African team is gearing up for the trial and is overcoming delays due to COVID-19. It has obtained ethics and regulatory approval for the study and the pieces are starting to fall into place, from contracts, documentation and training to recruiting volunteers. Mukwaya says sites may be ready to recruit participants towards the end of the year depending on an ongoing evaluation of the impact of COVID-19.
For Omony, the trial is a very positive move in its quest to improve testing and treatment for gonorrohoea, as well as breaking down stigma around STIs.
“Our clinic focuses on empowering young women to play active roles in their relationships and to advocate for themselves, negotiating safe sex practices, including partner treatment of STIs. We also do a lot of education surrounding causes, spread, symptoms and complications of STIs and encourage our participants to bring their partners in for treatment.”
The zoliflodacin study spans four countries in four continents and dovetails with GARDP’s commitment to ensure treatment is available to anyone who needs it, wherever they live.