The second study was a randomized, four-arm, placebo-controlled, post-challenge, timed-treatment study. Animals were treated with a single dose of ETI-204 (16 mg/kg IM) at 24, 36 or 48 hours after challenge with aerosolized B. anthracis spores. The primary endpoint was survival at 28 days after spore challenge. The group treated with ETI-204 (16 mg/kg IM) 24 hours post-challenge demonstrated a survival rate of 93% (13/14) which was statistically significantly higher than the 10% (1/10) survival rate seen in the control group. The groups treated with ETI-204 at 36 or 48 hours post-challenge demonstrated survival rates of 43% (6/14) and 29% (4/14), respectively.
A planned secondary analysis revealed that 100% (15/15) of animals dosed with ETI-204 before becoming bacteremic (having evidence of bacteria in the blood stream) survived, and 30% (8/27) of animals dosed with ETI-204 after becoming bacteremic survived. These results were presented, in part, at the recent ASM Biodefense and Emerging Diseases Research Meeting, Washington, DC, February 2013.
A third study examined the pre-challenge protection duration of ETI-204. The study was a randomized, blinded, four-arm, placebo-controlled study in animals dosed with ETI-204 prior to challenge with B. anthracis spores. Animals were administered a single dose of ETI-204 (16 mg/kg IM) at either 24, 48 or 72 hours prior to challenge with aerosolized B. anthracis spores. The primary endpoint was survival at 56 days after challenge. All animals receiving ETI-204 survived to 56 days post-challenge, regardless of the time ETI-204 was administered prior to challenge. Ninety percent (9/10) of animals dosed with placebo prior to challenge died within the first 14 days following
|SOURCE Elusys Therapeutics, Inc.|
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