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).

SOURCE Tranzyme Pharma