Salute e Benessere
Orexa Announces Positive Interim Data for its Phase 2 Trial in the Prevention of Post-Operative Ileus
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).
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:
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.
says CEO Prof. Ard Peeters .
said Prof. Alexander Mustea , Principal Investigator at Universitätsklinikum Bonn.
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.
View original content:https://www.prnewswire.co.uk/news-releases/orexa-announces-positive-interim-data-for-its-phase-2-trial-in-the-prevention-of-post-operative-ileus-302578762.html