Severe sepsis affects >1.5 million patients annually in Canada, the US, and Europe with mortality rates of 30% to 70% for septic shock. Xigris, (sold by Eli Lilly) is currently the only approved therapeutic for severe sepsis, its usage has been limited due to controversy surrounding safety and efficacy.
Through this project, Sirius Genomics completed a multicenter clinical study to validate a pharmacogenomic companion diagnostic the “Xigris Companion Diagnostic” (XCD). This was supposed to aid physicians in decision making, with the ultimate aim of increasing patient survival rates.
The company has completed the CMS 3 trial and review of the results showed that both tested markers did not meet the pre-specified endpoints of differential treatment effect on mortality. Based on these results, the company made the decision to not develop this product any further and sell the underlying intellectual property. Sirius Genomics has since closed.