#Netherlands #Orexa #ORE-001 #Post-Operative Ileus #Herpen

Orexa's Groundbreaking Phase 2 Trial Results

Orexa B.V., a prominent Dutch life sciences company, recently announced promising interim results from its ongoing Phase 2 trial focusing on the treatment of post-operative ileus (POI). The trial evaluates the efficacy of Orexa's leading compound, ORE-001, specifically targeting patients undergoing significant abdominal surgeries. This groundbreaking research aims to enhance recovery and nutritional status in patients, positioning Orexa at the forefront of medical innovation.

Trial Overview

The clinical trial, identified by EudraCT number 2022-503113-31-00-IN-002, is a meticulously designed multi-center study. It employs a randomized, double-blind, placebo-controlled method and aims to enroll between 100 to 120 female patients, notably those undergoing gynecologic procedures requiring longitudinal laparotomy. The trial is being conducted at various centers in Germany, with distinguished Prof. Alexander Mustea from Universitätsklinikum Bonn (UKB) leading as the principal investigator.

The interim analysis took place after 40 patients had been randomized, revealing a remarkably favorable safety profile for ORE-001, alongside compelling efficacy metrics. The data presented highlighted significant improvements in critical post-operative recovery indicators, underscoring the treatment's potential impact on patient well-being.

Key Findings

1. Enhanced Food Intake: Patients administered ORE-001 exhibited a 63% increase in lunchtime food consumption compared to those receiving the placebo. This marked improvement in nutritional intake is essential for recovering patients.
2. Accelerated Gastrointestinal Function: The first post-operative bowel movement occurred approximately one day earlier in the ORE-001 group. This early return of gastrointestinal function is crucial for overall recovery.
3. Minimized Gastrointestinal Dysfunction: The incidence of gastrointestinal dysfunction plummeted from 21% in the placebo cohort to a mere 6% for patients on ORE-001, showcasing the treatment's effectiveness.
4. Reduced Hospital Stay: The proportion of patients requiring extended hospitalization due to adverse events decreased significantly, from 31% in the placebo group to just 7% among those treated with ORE-001.

Next Steps for Orexa

Given the promising interim results, Orexa plans to conclude the current Phase 2A study ahead of schedule. The company aims to commence preparations for the subsequent Phase 2B/3 trials to continue evaluating ORE-001's efficacy and safety in preventing post-operative ileus.

CEO Prof. Ard Peeters expressed optimism over the outcomes, stating, "This is a remarkable outcome for a vulnerable patient population. ORE-001 not only enhances patient well-being but could also lead to significant reductions in healthcare costs through expedited recoveries and shorter hospital stays."

Prof. Alexander Mustea, the principal investigator, emphasized the clinical significance of the initial data: "ORE-001 has the potential to redefine the management of post-operative recovery, particularly for high-risk surgical populations."

Understanding Post-Operative Ileus

Post-Operative Ileus represents a delayed return to normal bowel function typically following abdominal surgeries. Its financial implications are staggering, costing around $750 million each year in the United States alone. This underscores the necessity for effective treatments like ORE-001.

About Orexa

Founded in 2016 and headquartered in Herpen, the Netherlands, Orexa B.V. is dedicated to the development of ORE-001. This innovative therapeutic is designed specifically to bolster food intake in patients facing critical nutritional challenges. The company's core focus areas include not only post-surgical recovery but also issues related to anorexia and malnutrition, extending to conditions such as sarcopenia and cachexia. To explore more about Orexa and its initiatives, visit www.orexa.eu.