Tranzyme Pharma, a leading biopharmaceutical company developing small molecule drugs for the treatment of gastrointestinal and metabolic diseases, has announced the initiation of a phase IIb clinical trial of its investigational drug, TZP-101, for the management of post-operative ileus (POI). TZP-101 is a potent ghrelin agonist that Tranzyme is developing as a first-in-class prokinetic agent for the treatment of POI and severe gastroparesis.
The POI phase IIb trial, now underway in the USA, Romania and Lithuania, is a multi centre, randomised, double-blind, placebo-controlled, dose-ranging study to assess the efficacy and safety of TZP-101 when administered as a 30 minute infusion to subjects undergoing major open abdominal surgery. The study has an adaptive randomisation design, and could potentially enrol up to 250 patients. The primary objective of this study is to assess the impact of TZP-101 on postoperative time to recovery of gastrointestinal (GI) function as defined by the time to first bowel movement. In addition to efficacy monitoring, routine clinical, laboratory and ECG monitoring will be performed to evaluate patient safety.
POI is a cause of significant morbidity in patients subjected to abdominal and other types of surgery and increases the duration and cost of hospitalisation. The economic and resource burden that POI places on the healthcare system stresses the importance of developing an effective and safe treatment for this indication.
"TZP-101 offers the potential to treat POI through a novel mechanism of action," said Vipin K. Garg, Ph.D, president and CEO of Tranzyme Pharma. "We are pleased to initiate this phase II programme which results from our internal research efforts and our proprietary chemistry-based drug discovery platform."
"It is exciting for Tranzyme that the TZP-101 programme has now entered the more advanced phase of the clinical development process," said Gordana Kosutic, MD, VP of Clinical and Regulatory Affairs for Tranzyme Pharma. "Tranzyme's pre-clinical data have clearly shown that TZP-101 restores motility of the gastrointestinal tract whether caused by surgical manipulations of the GI tract or aggravated by the use of drugs such as opioids. The ability of TZP-101 to treat several underlying causes of post-operative ileus will potentially make this drug a unique first-in-class treatment for this medical condition."