Why we’re endorsing the Kigali Declaration to tackle Neglected Tropical Diseases
Wellcome is formally endorsing the Kigali Declaration at the Malaria and Neglected Tropical Diseases (NTDs) Summit, hosted by the Government of Rwanda on 23 June 2022.
Treatments for snakebites already exist and yet the human toll from snakebites is one of the world's biggest hidden health crises. They are thought to result in over 100,000 deaths every year, and leave another 400,000 with life-changing disabilities, mostly in the poorest communities. To prevent this, we want to help make safe, effective, and accessible snakebite treatments a reality for everyone.
We want to help transform the way in which snakebite treatments are researched, developed and delivered. If successful, this will also serve as a model for other neglected tropical diseases (NTDs).
Antivenom is currently the only medicine for treating snakebite and it is made up of animal-derived antibodies – a 19th-century technology. There are no common production, safety, or efficacy standards, which means there is a high risk of antivenom being contaminated and causing adverse reactions. Large quantities of antivenom are often needed for successful treatment, and this can be highly costly for snakebite patients.
We want to modernise antivenom production by enhancing the science and applying technology to make products better, safer, and cheaper. We believe this can happen by working with the World Health Organization (WHO), antivenom producers, and other funders and delivery partners to build a regulatory system that gets more effective products to patients more rapidly.
WHO has identified a need to develop the first public-interest Target Product Profiles (TPPs) to support optimisation of current and emerging products to treat snakebite. TPPs can play a central role in the drug discovery and development process towards desired product characteristics, including access, equity, and affordability considerations.
We are supporting WHO to develop these TPPs with preferred and minimally acceptable profiles for antivenom therapeutics. An initial focus is on conventional antivenoms for Sub-Saharan Africa, to be followed by equivalent TPPs for South Asia and for both small molecule and engineered antibody therapeutics. The resultant TPPs will assist manufacturers, regulators, clinicians and researchers with product standardisation and guide more targeted research and development of antivenoms.
While exciting progress is being made in the development of the next generation of antivenoms and treatments, this will take time and interim solutions are urgently required to address snakebite. Fav-Afrique is a highly effective, polyspecific antivenom designed to treat envenoming by ten of the most dangerous venomous snake species in sub-Saharan Africa. It has not been in production since 2014.
We are supporting Wales-based pharmaceutical company MicroPharm to undertake the research underpinning the modernisation and simplification of the Fav-Afrique manufacturing process with a view to increasing yield and decreasing production costs. The aim of this project will be for MicroPharm to re-establish regular supplies of Fav-Afrique to Africa.
Antivenom treatments can be expensive to manufacture, have risky side effects, and are not always effective at neutralising snake venom.
It is essential we continue to explore the development of new and alternative treatments to traditional antivenoms which may be safer, effective against more snake species and with fewer doses, and possess manufacturing incentives resulting in more sustained production and availability.
We want to help develop the pipeline of new snakebite treatments and antivenoms by generating an evidence base for which treatments work and why.
Fast-acting small molecule drugs can be taken orally and enter cells easily due to their low molecular weight. They are relatively inexpensive to produce, work synergistically with antivenom, and can be given early during the critical time following a snakebite. While the antibodies present in antivenom target specific proteins, small molecule inhibitors with broad-spectrum activity have the potential to target whole toxin classes (e.g. venom sPLA2 or metalloprotease) leading to solutions that cover a broad range of snake venoms.
In conjunction with the standard of care that includes antivenom, we are supporting Ophirex to perform an India-focused Phase 2 human trial to evaluate the safety, tolerability, and efficacy of oral varespladib-methyl in adult and paediatric victims of snakebite envenoming. Varespladib is a potent, broad-spectrum inhibitor of venom sPLA2. The advancement of such broad-spectrum treatments for snakebite will provide more effective and affordable care that can be administered in any environment.
Until now, snakebite envenoming has never been regarded as a public health priority or as an issue of urgent concern. As a result, government and intergovernmental agencies have been slow to prioritise prevention of snakebites and integration of treatments into health systems. An unstable market for snakebite treatments has driven their costs up. This leads to the withdrawal of treatments from the market because poorer communities cannot sustain the price.
We will generate evidence about snakebite’s prevalence and economic cost. This information will help to underpin the development of a more robust market and integrate treatments into health systems where snakebites have most impact, particularly in low- and middle-income countries.
The Association of South East Asia Nations (ASEAN) is recognised as having one of the highest regional burdens of snakebite. However, the true magnitude, especially on economic aspects, remains unknown. The result is a lack of access to effective antivenom due to inadequate understanding of demand and supply in the antivenom market.
We supported this study by Professor Othman and his team to collect the clinical and antivenom market data, provide a more accurate assessment of the burden of snakebite, and project the clinical and economic implications of scenarios with various levels of antivenom availability in seven ASEAN countries. This will act as a critical first step in the development of national and regional action plans to address the burden of snakebite.
We believe an essential part of building and maintaining snakebite on the global agenda is investment in the next generation of snakebite researchers.
We are partnering with the Royal Society of Tropical Medicine and Hygiene on their Early Career Grants Programme (formerly known as the Small Grant Programme), which offers early career researchers up to £5,000 to deliver a research project over one year. We are supporting up to 10 of these awards each year on snakebite envenoming in low- and middle-income countries (LMICs). Projects can take place across the research spectrum of lab, translation, implementation, and policy.
The grants often represent the first opportunity for researchers to manage their own research projects and are intended to act as steppingstones to larger awards and enhanced skills. We hope that by offering these exciting and important opportunities we can help kick-start research careers and build the pipeline of global health researchers and leaders working in snakebite.
In 2019, we launched a seven year, £80 million programme, committed to transforming the way snakebite treatments are researched and delivered to help make them safe, effective, and accessible for all.
Following the publication of Wellcome’s new strategy we will continue to act as an integrated, impact-driven programme which will align with Wellcome’s ambitious goals and be underpinned by principles of diversity and inclusion and research culture. We believe adopting multidisciplinary approaches and working in areas that intersect with other global health priorities will be essential in our work to address snakebite. We remain committed to the translation of research and development into advancements in snakebite treatment, and tangible benefits to health outcomes.
We currently have an active portfolio of grants spanning across our ambition areas and aiming to improve snakebite health outcomes across the globe.
We are a global programme, supporting research projects that take place in, and involve stakeholders from over 30 countries:
The research locations listed here are broadly defined and include countries where research projects, administrative organisations, partnerships, consultations and other work relating to the projects we are supporting has been active.
Wellcome has consistently been the largest philanthropic funder of snakebite research and development in recent years, and we are pleased to see that global funding for snakebite has increased yearly since 2017 when it was added to the WHO's list of neglected tropical diseases.
We will continue helping to build and sustain global funding for snakebite research.
We've awarded more than £15 million in funding to support researchers working on innovative approaches to discover and develop next generation treatments for snakebite.
An overview of the current pipeline of snakebite treatments can be found below. With current marketed products far from covering the needs of patients, and the vast majority of investigational candidates in early-stage development, ongoing and long-term commitment from researchers and funders will be essential.
We recently commissioned a comprehensive review of the pipeline of snakebite drugs and biologics in development since 2015.
We hope this will provide a useful picture of what has happened in the field of snakebite treatment development in the past seven years and provide users with insights into the various treatment types in the pipeline and their development stages, the opportunities for investment and collaboration, and which marketed products have undergone clinical assessment and obtained regulatory approval.
Find out more about the snakebite treatment pipeline and access the full dataset through the interactive web-based portal here.
We've commissioned the first comprehensive look at funding for snakebite envenoming research globally between 2007-2018.
We hope this research helps those working in the snakebite field to see the gaps and possibilities for new solutions and collaborations.
If you have any questions about our programme or the research we are supporting, please contact us via email.
Senior Research Manager - Snakebite
Wellcome
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Wellcome is formally endorsing the Kigali Declaration at the Malaria and Neglected Tropical Diseases (NTDs) Summit, hosted by the Government of Rwanda on 23 June 2022.
Today, Wellcome announces an ambitious new £80 million programme to transform the way snakebite treatments are researched and delivered, to make them better, safer and more accessible for all.