Tranzyme Pharma and Norgine B.V., have initiated dosing of ulimorelin in the first of two, Phase 3 pivotal studies - ULISES (ULImorelin Safety and Efficacy Study). Ulimorelin is Tranzyme's intravenous promotility agent in development for the management of postoperative ileus (POI) in hospital and acute care settings. POI is the temporary cessation of normal bowel motility after surgery preventing transit of intestinal contents and tolerance of oral intake. Approximately 300 bowel surgery patients will be enrolled at sites across the US and Europe in each of the two studies, ULISES 007 and ULISES 008. The objective is to evaluate the efficacy and safety of two, once-daily, dosage regimens of ulimorelin (160 and 480µg/kg) in accelerating gastrointestinal (GI) recovery in patients undergoing partial bowel resection. The primary endpoint of the study is the time to GI recovery defined as the time to the latest of first bowel movement and first intake of solid food.
"Currently there are limited options for restoring GI function shortly after surgery, which is a critical component for post-surgical recovery," said Vipin K. Garg, PhD, President and CEO of Tranzyme. "We are committed to finding new and safe therapeutics for critical, unmet medical needs, and the commencement of this Phase 3 program is a vital step towards achieving that goal."
There are an estimated 360,000 bowel resection surgeries performed annually in the United States. In many cases POI results in an extended length of stay in the hospital, having a negative impact on the patient experience and placing a considerable economic burden on hospitals and healthcare providers worldwide.