Tranzyme Pharma Presents Data Demonstrating that TZP-101 (Ulimorelin) Restores Bowel Function in Patients with Postoperative Ileus (POI) Regardless of the Extent of Opioid Use
Poster Session Presentation - ASCRS 2010 Annual Scientific Meeting
RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--May 17, 2010 - Tranzyme Pharma today announced that Philippa Charlton, MD, Tranzyme's Medical Director, and her colleagues G. Bochicchio, J.C. Pezullo, G. Kosutic, and A. Senagore, will present a poster entitled “The Prokinetic Agent TZP-101 (a Ghrelin Agonist) Accelerates GI Recovery in Partial Colectomy Patients Independently of Total Opioid Use and Type of Surgery” at the upcoming 2010 Annual Scientific Meeting of the American Society of Colon and Rectal Surgeons (ASCRS; Minneapolis, May 15-19). The poster session will be held on Tuesday, May 18th in Exhibit Hall B of the Minneapolis Convention Center.
The presentation examines predictors of gastrointestinal (GI) recovery in surgical patients who have undergone partial large bowel resection. The results indicated that although opioid use prolonged recovery slightly, it did not impact the ability of TZP-101 to accelerate recovery of bowel function, consistent with its opioid-independent mechanism of action. Similarly, whereas the extent of opioid use varied by country (U.S., Romania, Lithuania, India), GI recovery in patients receiving TZP-101 was unaffected by the country in which it was tested further emphasizing that the efficacy of TZP-101 is not limited by the use of opioids for pain management.
POI is a multi-factorial, transient impairment of gastrointestinal (GI) motility following abdominal or other surgery. Symptoms include abdominal distention, pain, nausea and vomiting, and inability to pass stools and tolerate a solid diet. Delays in resuming a normal diet may lead to poor wound healing and increased risk of infection through a cascade of events. POI is associated with an increased length of hospital stay and concomitant costs, and is the most common cause of delayed hospital discharge after abdominal surgery. The prolonged hospitalization raises the possibility for serious pulmonary complications. In the United States alone, 2.4 million patients undergo abdominal surgery each year and experience delayed GI recovery (source: Premier Database).
Tranzyme is planning a Phase 3 program with TZP-101 for POI with the primary efficacy endpoint of “GI2” - the time to recovery of GI motility as defined by the later of first bowel movement (BM) and first solid food intake. The preceding Phase 2 study (which enrolled ~250 patients undergoing partial large bowel resection) demonstrated that TZP-101 reduced the time to GI2 by 23.3 hours over placebo (PBO), a difference both clinically and statistically significant (p<0.05). The proportion of patients who had early recovery of GI motility (within 72 hours), another endpoint with clinical significance, was markedly increased by TZP-101 over placebo (65% versus 25%, respectively; p = 0.004). The most typical and clinically important adverse events for the post-surgical population, nausea and vomiting, were also noticeably decreased in the TZP-101 group as compared to placebo. In the placebo group, nausea and vomiting were reported for 27% and 16% patients, respectively. In contrast, for the two most effective study doses, fewer than 5% of TZP-101 patients experienced nausea or vomiting, consistent with the strong GI prokinetic activity of TZP-101 and early recovery of GI motility (Senagore, et. al., Diseases of the Colon and Rectum, 2010).
About Ulimorelin (TZP-101)
Ulimorelin is an intravenous ghrelin agonist with potent prokinetic properties in clinical development for the treatment of gastrointestinal dysmotility conditions in acute care settings. Ulimorelin has been comprehensively studied in the management of severe gastroparesis and postoperative ileus (POI), and has the potential to treat other conditions requiring administration of intravenous prokinetic agents in critical care settings. The safety and pharmacokinetic profiles of ulimorelin have been extensively characterized in healthy subjects and patients across multiple dose levels, and the GI prokinetic properties of the compound have been well established.
About Tranzyme Pharma
Tranzyme Pharma is a late stage biopharmaceutical company developing novel small molecule macrocyclic drugs for both acute care (hospital-based) and chronic indications with significant unmet medical need. The Company's pipeline is derived from its proprietary MATCH™ technology and targets two validated GPCR drug targets, ghrelin and motilin.
For more information on Tranzyme, please visit: www.tranzyme.com.
Contact: Tranzyme Pharma
Vipin K. Garg, PhD, 919-313-4764
President and CEO
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VP, Business Development
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Corporate Communications Manager
Posted: May 2010