Orexa’s ORE-001 Shows Promising Phase 2 Signals
Orexa B.V., a life sciences company based in the Netherlands, has reported positive interim results from its ongoing phase 2 clinical trial of ORE-001, a novel candidate aimed at preventing 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 at Universitätsklinikum Bonn.
The trial is enrolling up to 120 female patients scheduled for gynaecologic surgery requiring longitudinal laparotomy – precisely the population in whom POI can lengthen recovery times and drive complications.
Following the randomisation of the first 40 patients, interim data have shown clinically meaningful improvements across several recovery markers for those receiving ORE-001 compared with placebo.
Patients treated with ORE-001 consumed 63% more of their post-operative lunch, an early and tangible indicator of gastrointestinal recovery. Time to first stool was brought forward by approximately one day, and the incidence of post-operative gastrointestinal dysfunction fell markedly – from 21% in the placebo group to just 6% with ORE-001.
Importantly for both patients and hospitals, the proportion of individuals requiring extended hospitalisation due to adverse events dropped from 31% to 7%, suggesting a pathway to shorter stays and smoother recoveries.
Orexa’s CEO hailed the findings as a remarkable outcome for a vulnerable patient population, noting that 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.
Echoing that view from the clinical front line, the study’s Principal Investigator at Universitätsklinikum Bonn described the early data as clinically very meaningful and important, adding that ORE-001 has the potential to redefine post-operative recovery management, particularly in high-risk surgical cohorts.
Given the strength of the interim analysis, Orexa plans to conclude the current phase 2A trial ahead of schedule and begin preparations for phase 2B/3 studies in the same indication.
Those next-stage trials are expected to further evaluate ORE-001’s efficacy and safety at scale, and to cement the candidate’s role in standardising the prevention of POI after major gynaecologic surgery.
In Conclusion
Early phase 2 findings for ORE-001 point to a significant clinical advance: faster return of gut function, fewer complications, and shorter hospital stays for women undergoing major abdominal procedures.
With the 2A study closing early and phase 2B/3 preparations under way, Orexa is moving decisively to validate these encouraging signals and bring a potentially practice-changing therapy closer to routine care.
News Credits: Orexa reports promising results in post-operative recovery trial
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