Orexa B.V., a Dutch life sciences company that is developing a new medicine that increases food intake and supports health in patients, announces that the first patient has been dosed in a Phase 2 clinical trial in the prevention of postoperative ileus.
The trial investigates whether patients who undergo major abdominal surgery will develop less gastrointestinal disturbances and will recover more quickly. Study 2022-503113-31-00-IN-002 (EudraCT number) is a multi-centre, randomized, double-blind, placebo-controlled study to investigate the efficacy of Orexa's lead compound ORE-001.
It will enrol 100 to 120 female patients who undergo gynaecologic surgery requiring longitudinal laparotomy. The study runs at multiple centres in Germany with lead investigator Prof. Alexander Mustae from Universitätsklinikum Bonn (UKB). The first patient is dosed on 11 January 2024 in Bonn.
"This is a major milestone for a company like Orexa to start its first clinical Phase 2 study," says Prof. Ard Peeters. He continues: "Finally we will be able to test our drug in patients.
“This first study is in a group where we can possibly prevent a so-called postoperative ileus. This is a serious complication, which affects up to 50% of patients in several patient groups and leads to patients being unable to eat and therefore recovering more slowly, resulting in prolonged hospitalization."
