Keeping sexually transmitted infections treatable
In 2020, an estimated 374 million new cases of curable sexually transmitted infections (STIs) (gonorrhoea, chlamydia, syphilis and trichomoniasis) occurred among 15-to 49-year-olds worldwide. This included 82 million cases of gonorrhoea, a number that is on the rise.
In 2020, 82 million cases of gonorrhoea occurred among 15-to 49-year-olds worldwide.
OUR PRIORITY: Developing a life-changing new treatment for gonorrhoea
Resistance of Neisseria gonorrhoeae to first-line antibiotics has grown rapidly in recent years, resulting in increasingly limited treatment options. In 2017–2018, 70 countries reported resistance to at least one antibiotic treatment, including azithromycin, ceftriaxone, cefixime, and ciprofloxacin.
Gonorrhoea complications disproportionally affect women and include pelvic inflammatory disease, ectopic pregnancy, infertility, and increased risk of HIV transmission. Effective, accessible, and affordable antimicrobial treatment is imperative for the management of gonorrhoea as a public health goal.
With new antibiotics taking more than 10 years and US$1.5 billion to develop, we cannot afford any delay. GARDP is acting now to ensure that gonorrhoea remains treatable for future generations.
In partnership with Entasis Therapeutics, GARDP is leading the late-stage development of a new antibiotic, zoliflodacin. Zoliflodacin is bactericidal, with a low frequency of resistance and potent antibacterial activity against N. gonorrheae, including multi-drug-resistant strains. GARDP is sponsoring the pivotal global phase 3 clinical study, which is funded with the support of our donors.
GARDP is acting now to ensure that gonorrhoea remains treatable for future generations.
BEHIND THE SCENES
BEHIND THE SCENES
Christopher Burns, President and CEO, Venatorx Pharmaceuticals (US)
We, like many others, suffered last year, but we're back up and running.
Addressing a public health challenge in Thailand
Thailand is one of the countries in which we are evaluating zoliflodacin. The trial sites—the Silom Community Clinic, the Institute of HIV Research and Innovation Foundation (IHRI), and the Bangrak STIs Center—are all based in Bangkok.
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A Neisseria gonorrhoeae infection is particularly insidious, as it often lacks symptoms. However, if left untreated, gonorrhoea can have serious and permanent consequences, including infertility, ectopic pregnancies, and an increased risk of contracting HIV. This trial is an opportunity to address this public health challenge, which particularly affects the at-risk groups our clinic serves: men who have sex with men, and transgender women.
2021 progress
OUR ACHIEVEMENTS
We have launched research projects that will improve our understanding of the disease and public health needs in target countries.
ADVANCed r&D
through several projects, including the development of an in vitro Hollow Fibre Infection Model (HFIM) to examine the pharmacodynamic dosing, bacterial kill, and resistance suppression of zoliflodacin against Neisseria gonorrhoeae
ACTIVATED
new countries and sites and recovered recruitment (following the impact of the COVID-19 pandemic) for the phase 3 trial of zoliflodacin, a potential treatment for gonorrhoea
led
key initiatives that will facilitate future access to zoliflodacin
R&D progress
In 2021, GARDP completed its hollow fibre work on zoliflodacin. This research, which was conducted at Örebro University Hospital, Sweden, aims to evaluate pharmacodynamic dosing, bacterial kill, and resistance suppression for zoliflodacin against Neisseria gonorrhoeae.
We have also launched research projects that will improve our understanding of the disease and public health needs in target countries. The Kenya Prevalence Survey on pregnant women and high-risk groups received approval, with the first site activation planned for 2022. The survey aims to estimate the burden of gonorrhoea and chlamydia among pregnant women and other high-risk populations.
Meanwhile, the WHO Research Project Review Panel (RP2) approved the Prevalence Survey protocol for estimating the frequency of bacterial STIs among pregnant women in Thailand, which GARDP has now submitted to the WHO Ethics Review Panel (ERC) for assessment. The operating model for this study is currently under review.
Finally, in South Africa, GARDP and Wits Reproductive Health and HIV (Wits RHI) signed an agreement to collaborate on a project that will examine resistance to current treatments in pregnant women with gonorrhoea, with GARDP funding the microbiology assessments. We have also agreed a similar collaboration with the Foundation for Professional Development (FPD), in which we will conduct a study to assess the STI screening and treatment strategy in order to reduce the STI burden in pregnant women.
Recovering recruitment for phase 3 trial
In 2019, GARDP and Entasis initiated the phase 3 trial of zoliflodacin, a potential treatment for gonorrhoea, with the first trial sites activated and patient recruitment started in the US in 2019 and in the Netherlands in 2020. During 2021, we opened the first sites in South Africa and Thailand, and ended the year with 14 trial sites activated.
Since June 2021, there has been a consistent improvement in recruitment as we managed the impact of the unpredictable COVID-19 pandemic, primarily at our sites in South Africa, Thailand, and the Netherlands.
October 2021 was our best month for recruitment and, to date, South Africa has been the top-recruiting country. In addition, South Africa’s participation is enabling the recruitment of a significant number of women, which is a critical outcome for the study.
GARDP also began working on adding new trial sites to the study by contacting potential locations in Belgium, South Africa, and the UK, as well as continuing to work intensively with current sites to enhance recruitment against the backdrop of COVID-19.
October 2021 was our best month for recruitment and, to date, South Africa has been the top-recruiting country.
Facilitating access in countries with the greatest need
GARDP further developed its draft access strategy for zoliflodacin in 2021—including updated regulatory and market access pathway scenarios—to support the product’s introduction in our territories following US FDA approval. We also signed a memorandum of understanding (MOU) with the Thailand Ministry of Public Health to improve treatment for gonorrhoea in the country by exploring timely access to new antibiotics like zoliflodacin.
In March 2021, GARDP initiated a series of actions to assess the evidence necessary to support the introduction and appropriate use of zoliflodacin in our territories. Our newly created Evidence Generation Working Group for zoliflodacin has had discussions on the focus and implementation of this evidence generation plan.
GARDP has also consulted with key experts in India, Kenya, Thailand, and South Africa to develop our understanding of STI management practices, the potential positioning of zoliflodacin, the added value of the treatment, and the additional evidence needed to support its appropriate use in these countries.
A second consultation phase, consisting of a survey of caregivers, has been concluded in South Africa and is underway in India and Thailand. To help evaluate data gaps between the FDA submission dossiers and country-specific requirements for registration, regulatory consultants have started assessments in Kenya and India and will soon begin similar work in South Africa and Thailand.
our next challenge?
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In 2022, we will continue to progress the development of zoliflodacin by increasing the recruitment target of the phase 3 trial, initiating the final drug product manufacturing process, and further defining the public health value through regulatory and access pathways to ensure the future
availability of a much-needed treatment option.
