Public Funding for Ludger Limited

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This project is to accelerate the development of a proof-of-concept prototype of **GlyHealth-COVID** - a medical technology we are designing to identify '**immunofrail**' individuals who are at high risk of becoming severely ill or dying from COVID-19\. Initially, it was thought that only the elderly would get very sick and die from COVID-19 but around 25% of deaths have been in those aged below 65 with severe sickness and death occurring even in young, apparently fit, individuals. Using current medical technology doctors cannot foresee which of their COVID-19 patients will have the worst health outcomes so they must guess - often with disastrous consequences. Our work is on early detection and prediction of the health trajectories of patients with chronic and acute inflammatory diseases (IDs). COVID-19 is an acute-ID which causes sickness and death in similar ways to chronic-IDs but at greatly accelerated speeds. Our analysis suggests that the most vulnerable COVID patients are 'immunofrail' individuals whose immune systems are exhausted and go into overdrive - but instead of killing the virus they produce an inflammatory storm that starts killing the person's own body cells. Immunofrailty is a concept we have developed during over a decade of research. It is a very complex condition with a wide range of causes that all lead to high levels of chronic inflammation. Current medical technology can only measure acute inflammation, not immunofrailty-related chronic inflammation. We have developed a medical technology called **GlyHealth** that reliably measures immunofrailty and chronic-inflammation in individuals from changes in **biomolecular patterns in their blood**. This can be done without interference from acute inflammation. Those patterns are signals that can predict dangerous inflammatory storms. GlyHealth-COVID is a streamlined version of a test called GlyHealth-IBD test that we have developed to help gastroenterologists caring for inflammatory bowel disease (IBD) patients. GlyHealth-IBD can reliably predict future inflammatory storms in IBD patients up to 18 months before the storms are powerful enough to cause damage, enabling early proactive treatment of the disease. The initial project is for us to take GlyHealth-IBD and adjust it to produce the GlyHealth-COVID prototype. This project extension is to expand the initial work and further validate our GlyHealth platform with additional testing & analysis of COVID-19 blood samples. We can then test its ability to identify immunofrail COVID-19 patients in an initial clinical study. If it performs like GlyHealth-IBD then GlyHealth-COVID would be able to reliably identify vulnerable COVID-19 patients from small (0.2ml) samples of their blood. The samples can be taken with easy-to-use fingerprick blood collection kits which can used at home.

This is a project to help women living with polycystic ovary syndrome (PCOS) in the Philippines. PCOS results from a hormonal imbalance that can lead to infertility, disordered menstrual cycle, masculinisation and weight gain. Long-term complications include diabetes and increased risk of ovarian cancer. PCOS is the major cause of female infertility in the Philippines with ~4.5M Filipinas living with PCOS, however healthcare for them is poor, focusing on surgical removal of ovaries. This has a devastating impact on the women, affecting their relationships (many cannot find or keep a husband), has its own health risks and is ruinously expensive - an ovariectomy costs the equivalent of 4 months salary for an office worker and 2 years salary for an unskilled worker. We are developing Hupela-PCOS-Filipina a programme to greatly improve the health outcomes of women living with PCOS in the Philippines. It has three elements: 1. Free Education Programme (EP) on self-care for PCOS without drugs or surgery. 2. Commercial programme to sell a Nutritional Supplement (NS) for PCOS treatment. 3. Develop Research Partnerships (RP) to advance healthcare for Filipinas with PCOS. This is a six month study to assess the feasibility of our project. The care protocols have been tested and proven to be safe and effective and we are now developing a business and technology plan (BTP) covering the next five years. This study will help us ensure the plan is sound through three types of activity: Perform field and investigative work to test our core assumptions on our potential market, customer demographics, our value proposition, the business model, profitability, scalability, potential impacts on us, our customers and their families and our partners and potential risks. Modify the BTP using knowledge gained in Step 1. Further develop relationships with partners needed to deliver a successful, sustainable programme in the Philippines. The proposed project aligns with UN Sustainable Development Goals 3 and 4, respectively. The project partners, Ludger and Masuna have collaborated on social enterprise projects to improve the health and wealth of Filipinos living in poverty. Over the past six years we have set up two businesses with a social mission in the Philippines. This project is a natural extension of that work. To promote local economic development and ensure the success and sustainability of the programme, we will also train and commission local women to deliver support groups and educational sessions for women with PCOS.

GlycanDx-MODY is a test to identify patients with HNF1A-type Maturity Onset Diabetes of the Young (MODY). This is a type of diabetes affecting up to 4% of diabetics (40K-160K cases in the UK) that can be treated with inexpensive oral drugs. Most MODY patients are misdiagnosed and prescribed insulin, which does not treat their disease, is inconvenient and expensive. In the long term, patients have a higher risk of blindness, kidney disease and heart disease. There are genetic tests available, but they are not widely used by GPs because they are too expensive and the results are difficult to interpret. This is a collaborative project led by Ludger, an Oxford based bioscience company, along with non-funded partners Genos (European SME) and OCDEM (Oxford diabetes research group). In a study of 200 diabetes patients the test positively identified those with HNF1A-MODY. The test is affordable (quarter of the price of genetic tests), quick (~ 3 days turnaround) and the results are easy to interpret. We would like to further develop this assay for routine clinical use as a diagnostic or screening tool. This Feasiblity Study is to plan the next stage in development and commercialisation of the test which will result in a blueprint to progress the project efficiently for the benefit of patients.