BERLIN – Today the UK government announced £3.5 million of funding to develop new treatments for gonorrhoea. It will enable global access, including in low-and middle-income countries (LMICs) where the burden of antimicrobial resistance (AMR) is greatest.
This investment will fund GARDP’s development of zoliflodacin, a first in class oral antibiotic for the treatment of drug-resistant gonorrhoea which is now in the penultimate stage of trials. This new oral antibiotic is a significant development as treatments for gonorrhoea are becoming less effective. Zoliflodacin is one of the few antibiotics in development to specifically treat gonorrhoea, an important consideration to reduce the risk of drug resistance – ensuring new treatments remain available and effective for generations to come.
UK Minister for Innovation, Nicola Blackwood, said: “The UK is a global leader in tackling antimicrobial resistance, a threat that is posing serious risks to health and the global economy, as well as killing hundreds of thousands of people around the world each year. It is vital to fund new antibiotic research and development to tackle AMR and this innovative project will develop solutions to treat the global rise of gonorrhoea and improve the quality of people’s lives.”
Dr Manica Balasegaram, Executive Director of GARDP, said: “We are excited to unveil our new strategy 5 BY 25 outlining GARDP’s ambition to accelerate the development of five new treatments by 2025. The recent initiation of the phase 3 trial of zoliflodacin is an important milestone towards bringing one of our five treatments a step closer to patients by 2025. The global nature of the trial, across four continents, represents our commitment to ensuring this treatment is available to anyone in need, wherever they live.”
GARDP will now undertake pharmaceutical development activities, and will develop a new strategy for access and appropriate use within LMICs that have a high number of cases of gonorrhoea.
Gonorrhoea is among the most common sexually-transmitted infections (STIs), with an estimated 87 million new cases occurring globally every year – and has been identified as posing a significant threat to global health by the World Health Organization (WHO).
Cases of gonorrhoea developing resistance to recommended treatments have emerged globally, including in the UK. Addressing drug-resistant infections is critical to achieving the Sustainable Development Goals, particularly the target for good health and well-being for all. There is now an urgent need for new treatment options, particularly for people in LMICs.
Gonorrhoea can have severe consequences on public health and, when left untreated, serious consequences for reproductive health as well as increased risk of transmission of HIV and other STIs. Women, and marginalized and vulnerable groups are disproportionately affected.
Zoliflodacin recently entered global pivotal phase 3 trials across four continents. These pivotal trials are designed to provide the evidence needed to approve a drug – a crucial step in the development of this treatment.
About the Global AMR Innovation Fund (GAMRIF):
The Department for Health and Social Care (DHSC) is the UK Government department which is responsible for helping people to live more independent, healthier lives for longer. The partnership with GARDP is part of DHSC’s Global Antimicrobial Resistance Innovation Fund (GAMRIF). GAMRIF was established to provide seed funding for innovative research and development, specifically in neglected and underinvested areas, in the field of AMR. GAMRIF is a £50m UK Aid investment, which means all projects funded must support research primarily and directly for the benefit of people in low- and middle-income countries (LMICs). The Fund takes a ‘One Health’ approach, seeking to invest in potential solutions to reduce the threat of AMR in humans, animals, fish and the environment. The Fund seeks to leverage additional global funding through interaction with international government bodies, public-private partnerships, product development partnerships, global funding mechanisms and global fora.
GARDP is a not-for-profit research and development (R&D) organization, co-founded by the World Health Organization and the Drugs for Neglected Disease initiative (DNDi) in 2016. As a core element of the Global Action Plan on Antimicrobial Resistance, GARDP is driving R&D in late-stage clinical development for treatments that meet the greatest public health needs. This includes those that target bacteria on WHO’s priority pathogen list, important infections and underserved populations, while ensuring sustainable access. Uniting against antibiotic resistance: delivering 5 BY 25 sets out how through working in partnerships, GARDP plans to develop five new treatments for bacterial infections by 2025, safeguarding their sustainable access so they are available to everyone, everywhere. GARDP is actively building a pipeline to address infections in children including newborns with sepsis, serious bacterial infections in hospitalized adults, as well as in sexually-transmitted infections.
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