Orexa B.V., a Netherlands-based life sciences company, has announced compelling 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 data, derived from 40 randomized patients, demonstrates significant improvements across multiple recovery metrics that could transform post-surgical care.
Trial Design and Patient Population
The multi-center, randomized, double-blind, placebo-controlled study (EudraCT number 2022-503113-31-00-IN-002) is being conducted at multiple centers in Germany under the leadership of Prof. Alexander Mustea from Universitätsklinikum Bonn. The trial is designed to enroll 100 to 120 female patients undergoing gynecologic surgery requiring longitudinal laparotomy.
Significant Clinical Improvements
The interim analysis revealed substantial benefits for patients receiving ORE-001 compared to placebo across several key recovery parameters. Most notably, patients treated with ORE-001 consumed 63% more lunch post-operatively compared to those receiving placebo, indicating improved nutritional intake during the critical recovery period.
Gastrointestinal function recovery showed marked acceleration, with patients experiencing their first post-operative stool approximately one day earlier than the placebo group. This faster return of bowel function represents a clinically meaningful improvement in post-surgical recovery.
The incidence of gastrointestinal dysfunction dropped dramatically from 21% in the placebo group to just 6% among patients receiving ORE-001. Additionally, the proportion of patients requiring extended hospitalization due to adverse events declined substantially from 31% to 7%, suggesting both improved safety and reduced healthcare burden.
Clinical and Economic Implications
Prof. Ard Peeters, CEO of Orexa, emphasized the broader implications of these findings: "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, the study's Principal Investigator, highlighted the clinical significance: "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."
Accelerated Development Timeline
Based on the strength of the interim results, Orexa has decided to conclude the current Phase 2A trial ahead of schedule and will begin preparations for Phase 2B/3 studies to further evaluate ORE-001 in the same indication. This acceleration reflects the company's confidence in the therapeutic potential demonstrated in the early data.
Market Context
Post-operative ileus represents a significant clinical and economic burden, with an estimated annual economic impact of approximately $750 million in the United States alone. The condition involves prolonged absence of bowel function after surgical procedures, particularly following abdominal surgery, making effective prevention strategies a critical unmet medical need.
Orexa, founded in 2016 and headquartered in Herpen, The Netherlands, is developing ORE-001 as a novel therapeutic designed to increase food intake in patients with critical nutritional needs. The company's focus areas extend beyond post-surgical recovery to include anorexia and malnutrition-related conditions such as sarcopenia and cachexia.
