US-based biopharmaceutical firm Rhythm has reported positive results from a Phase IIa clinical trial of relamorelin (RM-131) in patients with chronic constipation.
Relamorelin is a potent Phase II ghrelin agonist being developed to treat diabetic gastroparesis and GI functional disorders.
The results show that relamorelin administered once daily for two weeks in these patients significantly improves constipation symptoms, along with accelerating colonic transit.
A total of 48 patients were included in the randomised, double-blind, placebo-controlled, parallel-group trial, which evaluated the efficacy, safety, and pharmacodynamics (upper and lower GI transit) of relamorelin.
During the trial, patients received single-blinded placebo during a 14-day baseline phase, and those with an average of less than four bowel movements per week during baseline were randomised 1:1 to placebo or relamorelin 100mcg for the next 14 days.
The primary clinical endpoint of the trial was stool consistency based on the Bristol Stool Scale, while the primary pharmacodynamic endpoint was colonic transit.
The trial’s other major secondary endpoints included the number of spontaneous bowel movements (SBMs) per week, the number of complete SBMs, ease of passage, and time for first bowel movement (BM) after starting treatment.
Mayo Clinic gastroenterologist and the senior investigator for the trial Michael Camilleri said: "The results of this study demonstrate that relamorelin is effective in significantly improving constipation symptoms and accelerating gastric and colonic transit in patients with chronic constipation."
Rhythm CEO Keith Gottesdiener said: "We are excited about these study results because there is a need for new drugs to treat lower GI motility disorders, particularly refractory constipation.
"Relamorelin’s prokinetic mechanism of action and good safety profile makes it a compelling clinical candidate for refractory constipation, and also for patients with concurrent upper and lower GI motility dysfunction, both of which are prevalent in patients with Parkinson’s disease."
Currently, the company is also carrying out a Phase IIa clinical trial for chronic refractory constipation in Parkinson’s disease patients.
Additionally, the company has completed a Phase II trial of relamorelin to treat diabetic gastroparesis, and expects to start a Phase IIb clinical trial to treat diabetic gastroparesis by early 2015.