FDA study demonstrates potential for faster drug development
New cardiac safety methodology from iCardiac Technologies offers earlier cardiac safety characterisation
Rochester, NY-based iCardiac Technologies may have developed a way to help pharmaceutical companies detect which experimental drugs might fail over safety concerns.
The company recently completed a study with the US Food and Drug Administration (FDA) which demonstrated the ability of its Early Precision QT methodology to detect cardiac toxicity in drugs earlier in the development process.
The definitive validation of this approach included cardiac safety studies for five marketed drugs for which cardiac safety profiles are well known.
The testing was performed in a study design routinely used by pharmaceutical developers to characterise the safety of new compounds when given to humans for the first time (First-in-Human studies). The Early Precision QT methodology developed by iCardiac Technologies was used to analyse the electrocardiogram (ECG) data collected in the study and compare it with the known outcomes for each drug.
Access to more accurate cardiac safety data early in the clinical trials process can mean accelerating the development of promising drugs
The results showed that the Early Precision QT methodology substantially increases the data analysis precision compared with historical data analysis methods, which could potentially move cardiac safety testing upstream in the pharmaceutical R&D pipeline, from large and expensive studies in later phases to smaller and earlier First-in-Human studies.
Additionally, this approach is said to deliver a much lower than expected incidence of inconclusive results compared with historical assessment methodologies.
The company said the implications for the drug development process are 'very significant' and include the potential to 'reduce the cost and increase the speed and reliability of cardiac safety testing'.
This could reduce the over-reliance in the future on the more expensive Thorough QT (TQT) tests that have been used for the past 10 years.
'Access to more accurate cardiac safety data early in the clinical trials process can mean accelerating the development of promising drugs that might have been cancelled due to inconclusive or inaccurate results from the manual assessment processes currently in use by traditional ECG core laboratories,' said Alex Zapesochny, President and CEO of iCardiac Technologies.
'The Early Precision QT methodology analyses over 100 times the data when compared with traditional analysis methods, offering much earlier insights into the viability of drugs in development.'
