Agennix AG 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 centres across the US. 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 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 per cent in the placebo arm compared to 18.1 per cent in the talactoferrin arm, an absolute reduction of 11 per cent and relative reduction of 38 per cent (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 per cent in the placebo arm to 21.3 per cent in the talactoferrin arm, an absolute reduction of 14 per cent and relative reduction of 39 per cent (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 per cent was greater than the absolute reduction seen in 28-day all-cause mortality (which was 12 per cent, from 26.6 per cent in the placebo arm to 14.6 per cent 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.
“We are extremely pleased to see that the treatment effect of talactoferrin in severe sepsis appears to be sustained over a longer time period,” said Rajesh Malik, chief medical officer. “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.”
The above analyses were all conducted on an intent-to-treat (ITT) as-treated basis, meaning that patients were evaluated based on the treatment they actually received (talactoferrin or placebo).
Talactoferrin was shown to be very well tolerated in the study with no major differences in adverse events between the two treatment arms.
The phase-2 trial was primarily funded by a grant from the US National Institutes of Health.
The company plans to present data from the trial at an upcoming major medical meeting.
Sepsis is a condition involving known or suspected infection and generalized inflammation.
Talactoferrin is an oral novel targeted dendritic cell recruiter and activator being studied mainly for the treatment of cancer and severe sepsis.
Agennix AG is a publicly traded biopharmaceutical company that is developing novel therapies in areas of major unmet medical need to improve the length and quality of life of seriously ill patients.