The project, CARDIMMUN, aims to pursue development of the scientific findings from the FP6 project CVDImmune. Based on our patented discovery, that low levels of anti-PC (phosphorylcholine) indicate risk for future development of cardiovascular disease, we have developed both a diagnostic test (a marker to identify cardiovascular disease patients that are at high risk of secondary events) and a candidate drug - an innovative fully human monoclonal antibody antibody, PC-mAb - that can block vascular inflammation. Together, this forms a unique opportunity for a personalised medicine approach, with a companion diagnostic and a targeted intervention in an area that is still in great medical need, despite recent advances in therapy. PC-mAb is now ready for clinical development.
The project will be progressed, by a structured plan that brings together SMEs and selected academic partners, and integrates preclinical and clinical studies into a commercially viable and mature therapeutic modality. The 5 work packages will embrace concept testing in animal models using biomarkers applicable also in human disease, coronary flow reserve and glucose uptake in inflamed arteries, as well as required toxicity studies. Additionally, studies in man are planned that explores safety, pharmacokinetics, pharmacodynamics and indices of clinical efficacy, including a placebo-controlled Proof of Activity trial in patients.
Athera’s PC-mAb is targeting the market of reducing secondary cardiovascular events, focusing on high-risk patients with low anti-PC levels. According to plan, the data will enable a business agreement with Athera and a partner (probably big pharma) to enter into larger scale clinical trials by early 2017. PC-mAb could then be launched on the market as a new drug, with clear block-buster potential, by year 2020.
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