The drug is being developed in an attempt to bolster advances in cardiogenic shock (CS) treatment, which affects up to 10% of heart attack patients each year, in order to improve heart attack survival.
According to the company, Triumph will evaluate the effectiveness of the tilarginine acetate injection (TAI) in the reduction of all cause mortality in patients with CS. The randomized, double-blind, placebo-controlled trial will enroll 650 patients at over 120 sites in the US, Canada and Europe. Patients will be randomized to receive either TAI as a bolus and five hour infusion or as placebo.
Phase II of the drug involved a clinical research study which found a trend toward lower mortality in patients who were treated with the highest doses of TAI compared to those who received placebo.
“TAI represents a new way to intervene in this condition, and we believe that Triumph is a landmark study that, if successful, could provide a therapy to finally reduce mortality in patients with CS and change the way physicians approach the treatment of these high risk patients,” said Ian Gilchrist, principal investigator in the Triumph study. “We know that if patients with CS survive the first 30 days, they are likely to live for many years, and have the same mortality as heart attack patients without CS. We need new therapies to improve early survival.”