Thorough Preclinical Safety Package
It is estimated that approximately one third of compounds in pre-clinical development exhibit some level of cardiac risk. Of these, nearly 75% provide discordant results in traditional risk assessment assays leaving investigators confused about a compounds true risk or merit. Unfortunately, many of these discordances are not identified until the compounds are in clinical trials after millions of dollars and years of effort have been invested.
Why Are There Discordant Results?
The hERG channel plays a significant role in cardiac repolarization - acute hERG block alone will prolong QT and induce Torsades de Pointes. However, there are 13 known ion channels that play a role in excitation, contraction and repolarization of the heart, and compounds routinely inhibit or activate one or more of these other cardiac ion channels influencing the effect of hERG block. In addition, it has been reported that compound inhibition of ion channel trafficking from the endoplasmic reticulum to the cell membrane in the absence of channel block can result in the same effect as direct channel block.
Resolving Discordances Faster
& With More Certainty
ChanTest’s Thorough Preclinical Safety Package (TSP) provides a comprehensive preclinical cardiac safety assessment for full resolution of potential cardiac risk prior to IND submission. Multiple assays are employed to assess a compound’s effect on all cardiac ion channels at molecular, cellular and system levels. The TSP can also be used to resolve discordances between S7B recommended assays or issues identified during the clinical trial phase.
- fast, comprehensive cardiac safety assessment
- significantly lower costs compared to drug failure in the clinic
- guides IND-enabling study selection
- complete compound performance data and advice for IND submissions
The TSP is offered as a complete package, or individual assays can be selected for follow-up studies. For a quote or additional information, please email firstname.lastname@example.org or call 216-332-1665.