Ncardia (former Pluriomics) is an international Dutch/Belgian/German biotech company with the mission to implement stem cell technology in drug discovery and development. The company is specialized in developing stem cell-based cellular systems and assays for cardiac safety pharmacology and drug discovery and development. Ncardia developed a unique proprietary protocol to differentiate heart muscle cells derived from human induced pluripotent stem cells (hiPSCs). Ncardia provides its customers with reliable cell technology systems to test potential drugs in the preclinical phase with high predictive value.
Safety issues remain a key problem in drug development. This is amongst others emphasised by the case of AstraZeneca where 82% of pre-clinical and 62% of phase I project closures where related to safety issues (Cook D., Nat Rev Drug Discov, 2014). Out of the safety related failures the cardiovascular system is involved in 17% of the preclinical failures and 24% of the clinical failures. Examples of cardiovascular effects, include arrhythmias, hypertrophy, hypertension and reduced ventricular function, which may lead to increased cardiac risk and possibly death. Additional reasons for the decline in success rates are related to the lack of predictive models for early drug efficacy screening. These high attrition rates contribute considerably to the total costs of drug development, and since these costs need to be compensated by the earnings of marketed drugs this impacts the prices of drugs.
Ncardia has developed Pluricyte® Cardiomyocytes and integrated proprietary assay systems that are exceptionally well suited for implementation in various stages of drug discovery to improve decision-making, reduce attrition rates and provide an alternative for animal testing. Enabling market uptake and distribution of cell technology based innovations can be challenging, with large-scale production and development of regulatory compliant predictive models as main challenges. DeCISIoN will tackle these challenges and thus accelerate market uptake of Ncardia’s cardiac safety assays. In this project it will take the next steps and deliver
1) an up-scaled and more cost-effective manufacturing process;
2) novel, validated, predictive high-throughput cardiac assays for further improved cardiac toxicity and drug efficacy testing and
3) a fully developed marketing and commercialization strategy for the cardiac assays.
