Orexa B.V., a life sciences company based in the Netherlands, has announced positive interim results from its ongoing phase 2 trial investigating ORE-001 for the prevention of post-operative ileus (POI) in patients undergoing major abdominal surgery.
The multi-centre, double-blind, placebo-controlled study is being conducted in Germany and led by Prof. Alexander Mustea from Universitätsklinikum Bonn. It is enrolling up to 120 female patients undergoing gynecologic surgery requiring longitudinal laparotomy.
Following the randomisation of 40 patients, interim data revealed significant improvements in key recovery metrics for those receiving ORE-001.
Patients consumed 63% more lunch post-operatively compared to placebo, experienced their first stool approximately one day earlier and showed a marked reduction in gastrointestinal dysfunction, with incidence falling from 21% to 6%. Additionally, the proportion of patients requiring extended hospitalisation due to adverse events dropped from 31% to 7%.
Prof. Ard Peeters, CEO of Orexa, said: “This is a remarkable outcome for a vulnerable patient population. ORE-001 not only enhances patients well-being, but also has the potential to substantially reduce healthcare costs through faster recovery and shorter hospital stays.”
Prof. Alexander Mustea, Principal Investigator at Universitätsklinikum Bonn, explained: “The early data from this study are clinically very meaningful and important. ORE-001 has the potential to redefine how we manage post-operative recovery, particularly in high-risk surgical populations.”
In light of the promising results, Orexa will conclude the current phase 2A trial ahead of schedule and begin preparations for phase 2B / 3 studies to further evaluate ORE-001 in the same indication.
