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news.Agennix has announced longer-term mortality results from the talactoferrin randomized, double-blind, placebo-controlled Phase 2 trial in severe sepsis. The trial evaluated talactoferrin versus placebo in 190 adult patients with severe sepsis enrolled at 25 leading centers across the US.
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Patients in both arms received standard of care treatment for severe sepsis in an intensive care unit (ICU) setting. As previously reported, the trial achieved its primary endpoint of a reduction in 28-day all-cause mortality. The results announced today showed that talactoferrin also reduced all-cause mortality compared to placebo over the longer term – at three months and at six months.
Three-month all-cause mortality was 29.3% in the placebo arm compared to 18.1% in the talactoferrin arm, an absolute reduction of 11% and relative reduction of 38% (unadjusted two-tailed p-value = 0.07, odds ratio by logistic regression analysis = 0.53). When the results were adjusted for cardiovascular dysfunction, a major prognostic factor for severe sepsis, the two-tailed p-value was 0.09, and the odds ratio was 0.55.
At six months, there was a statistically significant reduction in all-cause mortality from 35.2% in the placebo arm to 21.3% in the talactoferrin arm, an absolute reduction of 14% and relative reduction of 39% (unadjusted two-tailed p-value = 0.04, odds ratio = 0.50; adjusted two-tailed p-value = 0.05, odds ratio = 0.51). The absolute reduction in six-month all-cause mortality of 14% was greater than the absolute reduction seen in 28-day all-cause mortality (which was 12%, from 26.6% in the placebo arm to 14.6% in the talactoferrin arm).
The results for three- and six-month all-cause mortality in the study were consistent and sustained for patients with and without cardiovascular dysfunction.
Rajesh Malik, chief medical officer of Agennix, said: “We are extremely pleased to see that the treatment effect of talactoferrin in severe sepsis appears to be sustained over a longer time period. There are currently very limited treatment options available, with only one drug approved specifically for severe sepsis, a disease that results in hundreds of thousands of deaths each year in the US and Europe alone. We plan to meet with regulatory authorities within the next few months to discuss plans for advancing talactoferrin for this indication.”