HERPEN, Netherlands, Oct. 9, 2025 /PRNewswire/ -- Orexa B.V., a Dutch life sciences company focused on improving recovery and nutritional status in patients, today announced positive interim results from its ongoing Phase 2 trial evaluating ORE-001 in the prevention of post-operative ileus (POI) in patients undergoing major abdominal surgery.
Study Overview
The clinical trial (EudraCT number 2022-503113-31-00-IN-002) is a multi-center, randomized, double-blind, placebo-controlled study designed to assess the efficacy and safety of Orexa's lead compound ORE-001. The Study is enrolling 100 to 120 female patients undergoing gynecologic surgery requiring longitudinal laparotomy. It is being conducted at multiple centers in Germany with lead investigator Prof. Alexander Mustea from Universitätsklinikum Bonn (UKB).
Interim Analysis Results
The interim analysis was conducted after 40 patients were randomized. The data demonstrated a favorable safety profile and compelling efficacy for ORE-001, with clinically significant improvements in key post-operative recovery metrics:
- Increased post-operative food intake: Patients receiving ORE-001 consumed 63% more lunch compared to placebo.
- Faster return of gastrointestinal function: First post-operative stool occurred approximately 1 day earlier with ORE-001.
- Reduced gastrointestinal dysfunction: Incidence dropped from 21% in the placebo group to 6% with ORE-001.
- Shorter hospital stays due to adverse events: The proportion of patients requiring extended hospitalization declined from 31% to 7%.
Next Steps
Based on the promising interim results, Orexa will conclude the current Phase 2A study ahead of schedule and initiate preparations for Phase 2B / 3 studies to further evaluate ORE-001 in the same indication.
"This is a remarkable outcome for a vulnerable patient population," says CEO Prof. Ard Peeters. "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."
"The early data from this study are clinically very meaningful and important," said Prof. Alexander Mustea, Principal Investigator at Universitätsklinikum Bonn. "ORE-001 has the potential to redefine how we manage post-operative recovery, particularly in high-risk surgical populations."
About Post-Operative Ileus:
Post-Operative Ileus (POI) is a prolonged absence of bowel function after surgical procedures, usually abdominal surgery. It is estimated that the economic impact of post-operative ileus is approximately 750 million dollars annually in the United States alone.
About Orexa:
Founded in 2016 and headquartered in Herpen, The Netherlands, Orexa B.V. is developing ORE-001, a novel therapeutic designed to increase food intake in patients with critical nutritional needs. The company's primary focus areas include post-surgical recovery, anorexia, and malnutrition-related conditions such as sarcopenia and cachexia.
For more information, see www.orexa.eu.
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