In-house development by BASF’s department Experimental Toxicology and Ecology will identify potential safety risks better and faster
In the development of novel drugs, early recognition of potential toxicological effects and their underlying mechanisms is of utmost importance. To support the cost- and time-effective development of new compounds with more favorable toxicological profiles, BASF subsidiary Metanomics Health has launched MetaMapTox, a powerful tool for biopharmaceutical safety research.
MetaMapTox is a service evaluating specific metabolomic patterns in vivo, enabling customers to identify better and faster potential safety risks of test compounds in in vivo studies of rats. The tool has been developed in-house by BASF’s Experimental Toxicology and Ecology unit and will be marketed through Metanomics Health.
Over a period of seven years, more than 500 chemical entities were thoroughly tested in vivo to generate and validate more than 100 metabolomic fingerprints of different toxicological modes of action. These data allow for a faster and better assessment of toxicological profiles of new chemical entities (nces), thereby enabling MetaMapTox to address key unmet needs for in vivo toxicology testing: predictability, understanding of a toxicology mechanism and the ability for translation to clinical use.
MetaMapTox has been technically validated by the Drug Safety Executive Council (DSEC), in a consortium approach of 12 leading biopharmaceutical companies following the goal to advance new technologies for the development of better and safer medicines worldwide.
It will be offered in two distinct service packages: MetaMapTox Screener and MetaMapTox Profiler.
MetaMapTox Screener enables lead optimisation in exploratory non-GLP (Good Laboratory Practice) tox programmes based on predictive metabolomic patterns in rat plasma in 14-day studies. Benefits include coverage of systemic toxicological profiles of nces and unique mechanistic understanding based on 25 specific and predictive toxicological modes of action (MoA) in 11 different target organs.
MetaMapTox Profiler targets early safety assessment in a preclinical GLP toxicology setting. It covers 46 validated toxicological modes of action in 17 different target organs. Key attributes are the potential to detect drug side effects (e.g. liver and thyroid injury) at an early stage and a detailed understanding of systemic toxicology of nces, both leading to an improved lead selection and guidance for further toxicological tests.
‘MetaMapTox Screener and MetaMapTox Profiler have been designed based on feedback by the DSEC, whose members confirmed their great interest in a tool that provides predictive toxicological assessments already in the exploratory non-GLP phase,’ said Tim Boelke, managing director of Metanomics Health. ‘ We are convinced that MetaMapTox addresses this key unmet need.’
‘MetaMapTox has been developed by an interdisciplinary BASF team over a period of more than seven years to obtain early information on the toxicological profile while reducing the number of animals used,’ added Bennard van Ravenzwaay, senior vice president, Experimental Toxicology and Ecology at BASF. ‘MetaMapTox is already in routine use at BASF, contributing to faster decision making and significant savings in terms of cost and time to market for the BASF Group.’