A research team at the Montreal Heart Institute has tested a theory that genetics may play a role in why even the most promising drugs fail to deliver in late-stage clinical trials. Dr. Marie-Pierre Dubé and her team are trying to understand if pharmacogenomics can explain why even the most promising targeted therapies fall short more than 50 percent of the time.
Dr. Dubé’s team decided to use genetic tools to study dalcetrapib, a failed cholesterol drug. Designed to raise “good” HDL cholesterol, dalcetrapib had not significantly reduced cardiovascular adverse events in a Phase 3 clinical trial.
Illumina’s HumanOmni2.5Exome BeadChip was used to determine if a group of subjects in the trial had indeed benefited from dalcetrapib. Genetic data showed a strong association between the effects of dalcetrapib and a specific allele on chromosome 16. Those with the protective genotype saw a 39 percent reduction in cardiovascular events than placebo. A genetics-guided Phase 3 clinical study is now underway. Read more on the study here.