Relamorelin: Phase IIa data

A double-blind, U.S. Phase IIa trial in 48 patients with chronic constipation showed that once-daily 100 µg subcutaneous relamorelin missed the primary clinical endpoint of improving mean stool consistency as measured by BSS score from baseline to day 14 vs. placebo (p=0.184). Relamorelin met the secondary endpoints of increasing the number of SBMs per week (p=0.002), complete SBMs per week (p=0.049), time to first BM (p=0.004) and ease of stool passage (p=0.042) from baseline to day 14 vs. placebo. On the primary pharmacodynamic endpoint, relamorelin significantly improved colonic transit from baseline at 32 hours (p=0.04) and 48 hours (p=0.017) vs. placebo. Additionally, relamorelin accelerated gastric emptying (p=0.027) and small bowel transit (p=0.051) from baseline to day 14 vs. placebo. Data were presented at the American College of Gastroenterology meeting in Philadelphia. ...