Periodic Reporting for period 1 - AnandaCor (Concept and feasibility assessment for AnandaCor, a fast melting tablet, as a diagnostic device in ischemic heart conditions.)
Reporting period: 2015-07-01 to 2015-12-31
The project addresses the work programme topic PHC 12-2015-1: Clinical research for the validation of biomarkers and/or diagnostic medical devices
Cardiovascular and ischemic heart conditions are highly prevalent in all industrialized countries, with over 2 million deaths per year and estimated external costs of nearly 110 billion € per annum in the European Union alone, there is an urgent need for effective diagnostics leading to active treatment.
The overall objective of our project is to clinically validate the medical test AnandaCor with its unique liberation mechanism. It renders AnandaCor a first line diagnostic medical tool to differentiate between obstructive coronary atherosclerosis and the actual ischemia in the micro-vasculature or in the myocardial cell itself. In possession of detailed insight into the mode of action, we will go through the entire clinical development path for AnandaCor to serve clinical decision making, avoid many invasive diagnostic interventions, enable earlier start of appropriate treatment and improve overall treatment outcomes for the patients.
The specific objective of the SME phase 1 project has been to elaborate a feasibility study.
We focused mainly on the following topics:
• Supply of the raw material: direct partnerships
• Qualification of the active pharmaceutical ingredient (API) to GMP-grade
• Elaboration of the necessary documents of the API, the product AnandaCor and for the first clinical trial
• IPR protection of Ananda Pharma GmbH by a PCT application
• Elaboration of a feasibility report including a strategic business plan for SME instrument phase 2
In the age group under 44 years only one percent of women and 1.4 percent of men have cardiac episodes. However, the incidence rises drastically at the age between 45 - 65 years.
In industrialized nations more than 20 % of women and 28 % of men aged 65 years suffer from cardiac episodes and coronary heart disease.
CVDs represent a huge market for diagnostics and therapy. Due to the increasing age of the overall population the incidence of coronary heart disease and ischemic heart disease will continue to rise.
To reduce currently predominant interventional therapies, caries a great potential to reduce overall costs for the health care system. Patients are naturally interested in diagnostic devices as non-invasive as possible.
The main impact of our project is a facilitated first line diagnostic approach. As innovative pharmaceutical formulation AnandaCor is easily to be integrated into the existing diagnostic path and into the market of diagnostic medical devices. Increased clinical availability will provide benefits for approx. 60 % of all patients with ischemic heart disease and decrease the number of hospitalisation and therefore contribute to the sustainability of the health care systems.