Elusys preclinical data

In cynomolgus monkeys exposed to aerosolized Bacillus anthracis spores, a single dose of 8 or 16 mg/kg intramuscular ETI-204 given at 18 or 24 hours post-challenge significantly improved 28-day survival rates vs. placebo (100% and 83%, respectively, vs. 0%). All animals treated with placebo died at 18 hours post-challenge. A similar second study in cynomolgus monkeys exposed to aerosolized Bacillus anthracis spores showed that a single dose of 16 mg/kg intramuscular ETI-204 given at 24 hours post-challenge significantly improved the 28-day survival rate vs. placebo (93% vs. 10%). Animals treated with ETI-204 at 36 or 48 hours post-challenge showed 28-day survival rates of 43% and 29%, respectively. A planned secondary analysis showed that 100% of animals treated with ETI-204 before becoming bacteremic - having evidence of bacteria in their blood stream - survived compared to 30% of animals treated with ETI-204 after becoming bacteremic.

A third study in cynomolgus monkeys showed that all animals treated with a single dose of 16 mg/kg intramuscular ETI-204 at 24, 48 or 72 hours prior to challenge with Bacillus anthracis spores survived to 56 days post-challenge. In contrast, 90% of animals who received placebo prior to challenge died within the first 14 days following challenge with Bacillus anthracis spores. All control animals developed bacteremia by 56 hours post-challenge, while 86% of animals treated with ETI-204 never developed detectable levels of bacteremia. ...