Orexa B.V., a Dutch life sciences company focused on improving recovery and nutritional status in patients, has reported positive interim results from its ongoing Phase 2 trial evaluating ORE-001 for the prevention of post-operative ileus (POI) in patients undergoing major abdominal surgery.

Post-Operative Ileus is a prolonged absence of bowel function after surgery, typically abdominal procedures. It is estimated to have an economic impact of approximately 750 million dollars annually in the United States.

The multi-center, randomized, double-blind, placebo-controlled study (EudraCT number 2022-503113-31-00-IN-002) is enrolling 100–120 female patients undergoing gynecologic surgery requiring longitudinal laparotomy. The trial is being conducted at multiple sites in Germany, with lead investigator Prof. Alexander Mustea at Universitätsklinikum Bonn.

Interim analysis after 40 patients were randomized showed a favourable safety profile and clinically meaningful improvements in key post-operative recovery metrics. Patients receiving ORE-001 consumed 63% more lunch compared to placebo, experienced first post-operative stool approximately one day earlier, and showed a reduction in gastrointestinal dysfunction from 21% in the placebo group to 6%. Additionally, the proportion of patients requiring extended hospitalization due to adverse events fell from 31% to 7%.

Based on these interim results, Orexa plans to conclude the current Phase 2A study ahead of schedule and prepare for Phase 2B / 3 trials to further evaluate ORE-001 in the same indication.

CEO Professor Ard Peeters 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.”

Professor Alexander Mustea, principal investigator at Universitätsklinikum Bonn, said: “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.”