The company intends to recruit around 350 patients at clinical sites of Western Europe and North America.
The primary endpoint of the trial is to establish the effect of talactoferrin on 28-day all-cause mortality while the secondary endpoints include three-month, six-month and twelve-month all-cause mortality.
The OASIS trial is investigating talactoferrin plus standard care compared to placebo plus standard care in adult patients with severe sepsis.
The results from the previous trials showed that the drug has demonstrated prominent activity in double-blind, placebo-controlled, randomized Phase II studies in non-small cell lung cancer (NSCLC) and in severe sepsis.
Agennix chief medical officer Rajesh Malik said building on the promising results from their earlier Phase II study with talactoferrin in severe sepsis, the OASIS trial should give them important insight into the potential utility of talactoferrin as a treatment for this major unmet medical need.