UK atrial fibrillation drug developer Xention launched a contract services unit – Metrion – this week, explaining that the idea is to cash in on the ion channel knowhow it developed while working on its own candidate medicines.
Metrion’s key focus will be cardiac testing services according to scientific director Marc Rogers, who told us that after the Comprehensive in vitro Pro Arrhythmia (CiPA) initiative regulators are advocating increased ion channel screening in drug development.
“The US FDA and other regulatory agencies have proposed to expand the list of in vitro cardiac ion channels that should be used for assessing cardiac risk, and to offset this increase in screening overhead by reducing the need for expensive preclinical animal model and clinical thorough QT testing.”
He added that: “Ion channels could be thought of as a niche offering, but every drug candidate regardless of therapeutic indication or target class needs to be shown to be free of cardiac risk and this is where our expertise will most commonly apply to pharma and biotech companies.”
"The real issue for drugmakers is that all kinds of new drug candidates can bind to and modulate cardiac ion channels, even if they are not designed to do this. Thus, all new drug candidates need to be tested in cardiac safety assays to determine this risk, be it on-target or off-target, and regarledless of whether they were designed as ion channel blockers."
Metrion is not the only CRO to recognize the opportunity created by regulatory demand for ion channel testing.
Last October, US contractor Charles River Laboratories (CRL) bought ChanTest citing US Food and Drug Administration (FDA) guidance and CiPa as drivers for the deal.
Stem cell development
The CiPA initiative is intended to help developers test if drug candidates are likely to cause arrhythmia using in vitro screening and in silico modelling. Results must then be confirmed using human cardiomyocytes, which is another area where Metrion will be involved.
Rogers told us “Metrion will be participating in a two year Eurostars SME grant-funded programme to develop novel phenotypic cardiomyocyte assays using induced pluripotent stem cells (iPS).”
“We will validate our assays and platforms with high quality in vitro data from our CiPA panel of human cardiac ion channels, and unlike most other cardiac safety CROs we can also validate our assays using native human cardiac cells.”