Periodic Reporting for period 3 - AGLYC (The First In Vitro Diagnostic Device for the Early Detection of Cardiac Ischemia) Reporting period: 2021-02-01 to 2022-06-30 Summary of the context and overall objectives of the project Cardiovascular diseases (CVD) are the leading cause of death/morbidity across the globe, accounting for around 31% of all the annual deaths. This means that more than 49 million Europeans are living with CVD. Early detection of ischemia (lack of blood flow to the heart) is essential to prevent the progression of heart damage and the irreversible tissue damage (necrosis) that can lead to heart failure or even death. The correct implementation of current treatments is highly dependent on early diagnosis and categorization of patients. However, there are no available biomarkers for the early detection of ischemic heart disease. In fact, almost 90% of the available diagnostic methods are based on the quantification of markers of irreversible damage and are not effective for the detection of ischemic damage at an initial stage when it is reversible. AGLYC is an innovative diagnostic tool for the early detection of ischemia in the absence of the irreversible damage of the tissue that demonstrates a high sensitivity in detecting the presence of ischemic heart disease at an early stage. Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far The work performed during the project is summarized below:1. Production of AGLYC reagents under GMP like conditions Production of clinical batches of the antibodies was successfully completed during the project. All batches were produced under GMP-like conditions and in accordance with regulatory requirements. Batches were produced in an appropriate amount to cover the clinical trials and to have back up material for possible reanalysis of clinical samples.2. Regulatory and quality managementDuring the project, GlyCardial Diagnostics completed the Technical file. This document includes the know-how and the preliminary pre-clinical and clinical data as well as all the technical information about the test development, verification, and validation. 3. Clinical validation of AGLYC The EDICA clinical trial was successfully completed (patient recruitment and 6-month follow-up period for each patient). After completion, pending queries from all sites were solved by site investigator teams and Close Site Visits were performed by CRO monitors. ApoJ-Glyc values have been successfully measured in all serum samples collected within the study using an ELISA methodology, and biomarker data together with the clinical parameters of patients have been used run the statistical analysis to test the diagnostic performance and prognostic characteristics of ApoJ-Glyc. Recruitment for Stress-induced ischemia and MIDA-MIVA clinical trials has been completed and ApoJ-Glyc values have been analysed for each study group in the trials. A complementary clinical trial was added to the clinical validation of the biomarker, in order to investigate the behaviour of ApoJ-Glyc in the presence of cardiovascular risk factors. 4. Protecting the Intellectual Property Rights A strong intellectual property (IP) strategy to protect the results obtained during the execution of the AGLYC project was implemented and executed. The IPR strategy is focused on the protection of the main aspects of the project.5. Commercialisation and operational strategy GlyCardial designed and applied a Commercialisation and Operational plan focussed on four main aspects: Technology watch and maintenance of IP; Marketing activities & branding; Market research; and Company scouting and contacts. Through all these Business Development activities GlyCardial validated and sharpened the value proposition of the novel biomarker, successfully generated awareness, and raised interest among international experts in the field.6. Drafting an investor ready business plan The market situation was continuously reviewed to evaluate and update the position and developments of all the main companies in the cardiac diagnostic testing space. In addition, an ongoing assessment of current biomarkers in testing and/or use in the clinical practice for the management of ischemic events was carried out to update the competitive advantage of the novel biomarker. 7. Implementing an effective operational and marketing strategy A Communication and Dissemination plan was defined and implemented during the project. This plan assured the appropriate diffusion of the project updates according to the company needs, tackled the key stakeholders in the value chain for the market entry and commercialisation of the novel biomarker and allowed an interconnected multi-channel approach (combining online and offline tools and events) to raise the necessary awareness on the novel diagnostic solution. The implementation of the designed Commercialisation and Operational strategy successfully brought GlyCardial’s solution closer to the market. Importantly, the results of the EDICA trial were accepted to be presented at the congress of the European Society of Cardiology 2022, which is the most relevant scientific and industry congress in the field of cardiovascular disease worldwide. Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far) Cardiovascular diseases (CVD) are the leading cause of death/morbidity across the globe. Early detection of ischemia is essential to prevent the progression of heart damage and the irreversible tissue damage (necrosis) that can lead to heart failure. AGLYC is a lab-based test for the early detection of ischemia (15 mins event onset) in the absence of the irreversible necrosis of the tissue based on the measurement of Apo J-Glyc levels as a novel biomarker for the diagnosis, prognosis and risk stratification of ischemia and ischemic tissue damage.The AGLYC project addresses the bio-sanitary sector, specifically the field of cardiovascular medicine. AGLYC novel test will reduce the elapsed time between the ischemic event onset and decision making by cardiologists, leading to a significant reduction of the social impact of the disease and its associated economic costs. MWC March 2022 Matchmaking event Fenin - 2021 10 14 Tech Spirit Barcelona - 2021 11 22 Best Start-up EU
