The service - which will be provided by BASF's metabolite profiling subsidiary Metanomics Health - is based on MetaMap Tox, a list of 100 metabolic fingerprints based on data from 500 chemical entities analysed over the last seven years.
BASF claims that in addition to reducing the number of animals used the service allows for in vivo testing that is faster and offers greater predictability than histophatology, which is the current "gold standard" for in-vivo regulatory safety assessment.
The service comprises two packages: Screener for non-GLP lead optimisation based on predictive metabolomics patterns in rat plasma in 14-day studies; and Profiler for GLP validated toxicology assessments with a focus on detecting potential side effects.
Metanomics Health managing director Tim Boelke told Outsourcing-pharma.com that shifting dynamics in the field of pharmaceutical development – particularly related to drug safety – prompted the launch of the service.
“The risk-benefit balance in NCE portfolios is shifting towards improving the risk profile. As a consequence Pharma companies adopt a new strategic direction by frontloading toxicology decisions to early stages.”
He also suggested that the platform has a number of advantages over currently testing procedures, citing speed among the key benefits.
“Time savings arise when the results of a necessary carcinogenicity study trigger further mechanistic tests, which can potentially be avoided or be conducted earlier applying MetaMap Tox Profiler 28d as this product provides you with a comprehensive picture on toxicological MoAs” he said, predicting that customers could save between 6 and 9 months in time-to-market.
Industry input
The platform has been validated by the Drug Safety Executive Council (DSEC), an online community made up of biopharmaceutical firms, CROs, academics and government bodies focused on improving the safety of medicine development.
The organisation played an important role in assessing MetaMap Tox according to Boelke, who said that DSEC “members confirmed their great interest in a tool that provides predictive toxicological assessments already ion the exploratory non-GLP phase.”
He added that: “The potential for BASF-Metanomics Health is to establish MetaMap Tox as a standard product for new pre-clinical NCE assessment with the mid- to long-term objective to establish safety biomarker for clinical use.”