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 management
During 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.
