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, Metanomics Health GmbH is launching MetaMap®Tox, a powerful tool for biopharmaceutical safety research. MetaMap®Tox is a service evaluating specific metabolomic patterns in vivo, enabling customers to better and faster identify potential safety risks of test compounds in in vivo studies of rats.
MetaMap®Tox 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). MetaMap®Tox thereby addresses key unmet needs for in vivo toxicology testing: predictability, understanding of a toxicology mechanism and the ability for translation to clinical use.
MetaMap®Tox has been technically validated by the Drug Safety Executive Council (DSEC), in a consortium approach of twelve 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: MetaMap®Tox Screener and MetaMap®Tox Profiler.
MetaMap®Tox Screener enables lead optimization in exploratory non-GLP (Good Laboratory Practice) tox programs 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 & predictive toxicological modes of action (MoA) in 11 different target organs.
MetaMap®Tox Profiler is targeting early safety assessment in a preclinical GLP toxicology setting. MetaMap®Tox Profiler covers 46 validated toxicological modes of action (MoA) in a total of 17 different target organs. Key attributes comprise 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.
"We are very happy to launch MetaMap®Tox Screener and MetaMap®Tox Profiler," said Tim Boelke, Managing Director of Metanomics Health. "These 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. We are convinced that MetaMap®Tox addresses this key unmet need."
"MetaMap®Tox has been developed by an interdisciplinary BASF team over a period of more than seven years to obtain early information on the toxicological profile whilst reducing the number of animals used," said Bennard van Ravenzwaay, Senior Vice President, Experimental Toxicology and Ecology at BASF. "MetaMap®Tox 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."